Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JANET REHNQUIST 

INSPECTOR GENERAL 

MAY 2002 

OEI-01-97-00198 

CLINICAL TRIAL WEB SITES 

A Promising Tool to 

Foster Informed Consent 
OFFICE OF INSPECTOR GENERAL

http://www.oig.hhs.gov/ 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, 

is to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as 

the health and welfare of beneficiaries served by those programs. This statutory mission is carried out 

through a nationwide network of audits, investigations, and inspections conducted by the following 

operating components: 

Office of Audit Services 

The OIG's Office of Audit Services (OAS) provides all auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits examine the 

performance of HHS programs and/or its grantees and contractors in carrying out their respective 

responsibilities and are intended to provide independent assessments of HHS programs and operations in 

order to reduce waste, abuse, and mismanagement and to promote economy and efficiency throughout the 

Department. 

Office of Evaluation and Inspections 

The OIG's Office of Evaluation and Inspections (OEI) conducts short-term management and program 

evaluations (called inspections) that focus on issues of concern to the Department, the Congress, and the 

public. The findings and recommendations contained in the inspections reports generate rapid, accurate, 

and up-to-date information on the efficiency, vulnerability, and effectiveness of departmental programs. 

Office of Investigations 

The OIG's Office of Investigations (OI) conducts criminal, civil, and administrative investigations of 

allegations of wrongdoing in HHS programs or to HHS beneficiaries and of unjust enrichment by 

providers. The investigative efforts of OI lead to criminal convictions, administrative sanctions, or civil 

monetary penalties. The OI also oversees State Medicaid fraud control units which investigate and 

prosecute fraud and patient abuse in the Medicaid program. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 

advice and opinions on HHS programs and operations and providing all legal support in OIG’s internal 

operations. The OCIG imposes program exclusions and civil monetary penalties on health care providers 

and litigates those actions within the Department. The OCIG also represents OIG in the global settlement 

of cases arising under the Civil False Claims Act, develops and monitors corporate integrity agreements, 

develops model compliance plans, renders advisory opinions on OIG sanctions to the health care 

community, and issues fraud alerts and other industry guidance. 
EXECUTIVE SUMMARY 

PURPOSE 

To assess the role of clinical trial Web sites in fostering informed consent and of institutional 

review boards in overseeing the information on these Web sites. 

BACKGROUND 

In a June 2000 report, Recruiting Human Subjects: Pressures in Industry SponsoredClinical Research, we examined the strategies sponsors and investigators use to recruit human 

subjects for clinical trials. In this report, we take a closer look at a new recruitment vehicle: 

clinical trial Web sites. These Web sites provide a significant opportunity not only to recruit 

human subjects, but also to foster informed consent by increasing the amount of information that 

is available to an individual interested in a clinical trial. In this report we focus on the latter 

opportunity. Given the central role institutional review boards (IRBs) have in ensuring informed 

consent, we also look at their role in overseeing the information on these Web sites. 

In conducting this inquiry, we reviewed 22 clinical trial Web sites and 110 clinical trial listings 

on those sites. We analyzed both the general clinical trial information and the trial-specific 

information presented on these Web sites. We also interviewed Web site representatives, IRB 

members, and Federal officials. 

FINDINGS 

Clinical trial Web sites are emerging as an important recruitment strategy. 

Clinical trial Web sites are growing in popularity. Total visitors on the National Cancer 

Institute’s Web site, CancerNet, increased from an average of 500,000 visitors per week in 

May 2000 to an average of 700,000 visitors per week in May 2001. Another site, 

CenterWatch, saw the average number of visitors increase from 38,000 in 1997 to 334,000 in 

2000.1 Furthermore, these Web sites offer benefits as a recruitment vehicle: access to a large 

number of individuals, services that allow for personalization, and the potential to reduce costs 

associated with recruitment. 

Clinical Trial Web Sites i OEI-01-97-00198 
Clinical trial Web sites show promise as a means of fostering informed consent. 

Most of the Web sites we reviewed provide valuable general and trial-specific 

information about clinical trials. 

In our review of general clinical trial information on 22 Web sites we found that: 

<21 explain the importance of informed consent. 

<16 describe the role of IRBs in protecting human subjects. 

<16 explain the overall purpose of clinical trials. 

In our review of trial-specific information in 110 clinical trial listings we found that: 

<91 provide eligibility criteria. 

<80 provide a clear statement of the trial’s purpose. 

But clinical trial Web sites fail to take full advantage of their potential to foster 

informed consent. 

Most of the clinical trial listings we reviewed exclude key information. In our review of 

110 clinical trial listings, we found shortcomings in the following areas: 

<Trial benefits and risks. Not one has any information about risks to human subjects, while 

29 describe the benefits. 

<Sponsor name. 77 fail to identify the sponsor for the clinical trial. 

<Phase of trial. 69 do not indicate the phase of the clinical trial. 

<Description of trial. 56 lack a general description of the protocol. 

Some Web sites provide misleading general clinical trial information. For example, one 

Web site inaccurately describes phase one trials by saying the chances of a successful treatment 

are good, when in fact such trials are conducted to test safety. Another suggests that clinical 

trials provide access to new drug treatments, when in fact they involve the use of experimental 

drugs, not proven treatments. 

Most Web sites that collect personal information fail to disclose how they will use the 

information. In our review of 13 online privacy policies from Web sites that collect personal 

information, we found that: 

<11 do not indicate how long the Web site stores such information. 

<9 do not describe their processes to ensure that such information is securely transmitted over 

the Internet. 

Clinical Trial Web Sites ii OEI-01-97-00198 
Web sites provide minimal information about their financial relationships. Of the 12 

Web sites that generate revenue, half fail to disclose how they do so. 

IRBs face major challenges in reviewing clinical trial Web sites. 

Federal guidance for IRBs fails to make clear when a clinical trial listing requires review and 

fails to address privacy issues surrounding prescreening through the Internet. IRBs have limited 

leverage over general information on Web sites because it is outside their purview. Finally, 

many IRBs are already overburdened by increased workloads and lack the resources to take 

on the additional responsibility of reviewing clinical trial listings. 

RECOMMENDATIONS 

We direct three recommendations jointly to FDA and the Office for Human Research 

Protections (OHRP). Both of these entities issue guidance to IRBs and rely on them to ensure 

adherence to federal regulations that afford protections to human subjects. 

IRB OVERSIGHT. Provide further guidance to IRBs on clinical trial Web sites. 

Clarify that risk and benefit information in trial listings should be subject to IRB review and 

approval. In addition, any prescreening used for specific trials that collect personal information 

should be reviewed and approved by an IRB. In reviewing prescreening mechanisms specific 

attention should be given to privacy and confidentiality issues. 

VOLUNTARY STANDARDS. Facilitate the adoption and use of voluntary 

standards for clinical trial Web sites. 

Through workshops and other forums for deliberations, FDA and OHRP should exert 

leadership to foster the development and application of voluntary standards for clinical trial 

Web sites. On the basis of our inquiry, we suggest four standards that focus on maximizing the 

Web site’s potential to foster informed consent. They call for a comprehensive overview of 

clinical trials, key information in clinical trial listings, and prominent disclosure of privacy policies 

and significant financial relationships (see page iv). The standards go beyond the risk-benefit 

and prescreening information for which we call for mandatory IRB review and approval. 

INDEPENDENT REVIEW. Encourage clinical trial Web sites to undergo periodic 

review by independent bodies. 

Periodic review of clinical trial Web sites will help ensure that information provided by them is 

balanced and not misleading or coercive. These reviews could address general clinical trial 

information provided on the Web sites and examine their privacy policies and procedures 

surrounding personal information. Reviews could be conducted by IRBs and/or accrediting 

bodies. 

Clinical Trial Web Sites iii OEI-01-97-00198 
Standards for Clinical Trial Web Sites: 

A Preliminary Framework 

Standards Elements 

General Clinical Trial Information 

Provide a comprehensive 

overview of clinical trials 

The more subjects know 

about the process in general 

the more informed their 

decision to enroll will be. 

A comprehensive overview includes: 

< Clear statement that a clinical trial is research not treatment 

< Description of FDA’s drug approval process 

< Description of the Common Rule and FDA Good Clinical 

Practice regulations 

< Description of the informed consent process 

< Description of the role of IRBs 

< Explanation of the importance of weighing risks and benefits 

< Information on how to contact key Federal agencies for further 

clinical trial information 

< Sources of clinical trial information 

< Explanation of the importance of considering alternatives to a 

clinical trial. 

Disclose prominently a 

comprehensive 

privacy/confidentially policy 

Disclosure gives consumers 

control over their personal 

information before they share 

it. 

aware of how their personal 

information will be used. 

A comprehensive policy contains the following with regards to 

personally identifiable information: 

< How long is personal information retained 

< What information is collected 

< How information will be used 

< What entities or individuals have access 

< How consumers can eliminate personally identifiable 

information 

< When the policy was last updated 

Consumers should be fully 

Disclose prominently 

significant financial 

relationships 

Informs the subject of 

potential conflicts of interest 

the Web site may have. 

Significant financial relationships include: 

< Revenues collected based on Web site services 

< Funding the site receives from pharmaceutical companies, 

health insurers, trial sites, etc. 

< Agreements for advertising on the site 

Trial-Specific Information 

Provide key information in 

clinical trial listings 

Key information about specific 

trials helps the subject more 

quickly identify appropriate 

trials. 

Key trial information includes: 

< Title 

< Phase 

< Purpose 

< Description of trial 

< Eligibility criteria 

< Duration of trial 

< Time commitment for the subject 

< Balanced description of risks and benefits 

< Compensation for injury 

< Name of trial sponsor(s) 

< Name of clinical investigator(s) 

< Contact information for research site(s) - contact name, phone 

number, and location 

SOURCE: Office of Inspector General. 

Clinical Trial Web Sites iv OEI-01-97-00198 
COMMENTS ON THE DRAFT REPORT 

We received comments on the draft report from the Food and Drug Administration, the Office for 

Human Research Protections, and the National Institutes of Health. Each agreed with the thrust of our 

report and offered a number of comments. Below we summarize their comments and, in italics, offer 

our response to them. In this final report, we made some technical changes and clarifications in 

response to the comments. The full text of the comments appears in Appendix E. 

Food and Drug Administration 

The Food and Drug Administration indicated that it will be addressing our recommendations as it 

revises its Information Sheets for IRBs and Clinical Investigators. However, FDA expressed concern 

about the potential burdens to the already overburdened IRBs. As a way of easing the burden, it 

suggested that Federal guidance might call for IRBs to limit theirs reviews of trial-specific information to 

that information not considered basic trial information. We modified our recommendations to focus 

IRB review and approval to the risk and benefit information and prescreening questions for trial 

listings. 

Office for Human Research Protections 

The Office for Human Research Protections emphasizes that clinical trial web sites have not only the 

potential, but also a requirement to foster informed consent. Even basic trial information, it states, is 

subject to IRB review. If further guidance is needed to make this clear, it urges that it be issued. 

OHRP’s response focused on Web sites for institutions that received federal funds and are under 

the purview of those institutions. Our review included these sites but also others that are not 

part of any research institution. We suggest that FDA and OHRP work together to produce a 

common set of expectations for all Web sites. The preliminary standards we propose may be 

helpful in this regard. 

National Institutes of Health 

The National Institutes of Health, among a number of technical comments, asked for further clarification 

addressing the IRB’s responsibility for Web site trial listings beyond the local sites. In our report, we 

added language specifying that a local investigator or a sponsor initiating a trial listing that 

includes more than basic trial information is responsible for obtaining IRB approval. 

Clinical Trial Web Sites v OEI-01-97-00198 
TABLE OF CONTENTS 

EXECUTIVE SUMMARY ...................................................... i

INTRODUCTION ............................................................. 1

CLINICAL TRIAL WEB SITES: AN OVERVIEW ................................. 4

FINDINGS 

Emerging Importance for Recruitment Strategy ................................... 5

Promising Means of Fostering Informed Consent ................................. 7

Shortfalls of Clinical Trial Web Sites .......................................... 10

Challenges Facing IRBs ................................................... 13

RECOMMENDATIONS 

IRB Oversight .......................................................... 16

Voluntary Standards ...................................................... 17

Independent Review ...................................................... 17

COMMENTS ON THE DRAFT REPORT ....................................... 19

APPENDICES 

A: Main Players in Clinical Research .......................................... 20

B: Best Practices of Clinical Trial Web Sites .................................... 21

C: Standards from Health Internet Organizations ................................. 27

D: Summary Data of Web Site Review ........................................ 31

E: Full Text of Comments on the Draft Report ................................... 34

F: Endnotes ............................................................ 40

ACKNOWLEDGMENTS ..................................................... 44

Clinical Trial Web Sites vi OEI-01-97-00198 
INTRODUCTION 

PURPOSE 

To assess the role of clinical trial Web sites in fostering informed consent and of institutional 

review boards in overseeing the information on these Web sites. 

BACKGROUND 

Clinical investigators and sponsors of clinical trials, typically pharmaceutical companies, often 

have difficulties finding a sufficient number of human subjects to participate in clinical trials (see 

appendix A for an overview of the clinical trial process). These difficulties slow down the 

process of bringing new drugs to market, increase costs, and delay access to new and 

potentially useful drugs. In a June 2000 report, Recruiting Human Subjects: Pressures in 

Industry Sponsored-Clinical Research (OEI-01-97-00195), we examined the strategies 

sponsors and investigators use to recruit human subjects. In this follow-up report, we look at a 

new recruitment vehicle: clinical trial Web sites (see primer on page 4). Given the central role 

institutional review boards (IRBs) have in ensuring informed consent, we also look at their role 

in overseeing the information on these Web sites. 

Web sites as an Opportunity to Recruit Human Subjects 

The Internet offers clinical trial Web sites a unique opportunity for clinical investigators and 

sponsors to target individuals with an interest in clinical trials. These Web sites are portals for 

clinical trial information that can be accessed anytime by any individual with access to the 

Internet. In this report, we begin by offering some background on the growth of these Web 

sites and the factors propelling them as a recruitment vehicle. 

Web Sites as an Opportunity to Foster Informed Consent 

No less significant than the above opportunity is the one that these Web sites offer to facilitate 

informed consent among those individuals who decide to become human subjects in a clinical 

trial. These Web sites have an opportunity to raise the awareness and understanding of clinical 

trials by increasing the amount of information available to these individuals and, thereby, 

fostering informed consent. It is this opportunity that serves as the main focus of this report. 

Obtaining informed consent has long served as one of the bedrock elements of protecting 

human subjects. In 1978, the influential Belmont Report, issued by the National Commission 

for the Protection of Human Research Subjects, set forth three essential 

Clinical Trial Web Sites 1 OEI-01-97-00198 
elements to informed consent: (1) information — accurate and balanced information that helps 

individuals make a reasoned decision to participate or not; (2) comprehension — information 

presented in ways that facilitate understanding; and (3) voluntariness — information presented 

under conditions free of coercion and undue influence.2 

Clinical trial Web sites afford an opportunity to foster informed consent that can help meet the 

elements outlined in the Belmont Report. These sites provide access to both general and trialspecific information. The Internet allows individuals as much time as they need to thoroughly 

review and comprehend this information. Web sites can foster informed consent by presenting 

clinical trial information that helps individuals make balanced assessments of risks and benefits 

and prepare questions for clinical investigators, research coordinators, and their own 

physicians. These sites are not a substitute for the discussion that takes place between the 

individual and physician, but an opportunity to raise the awareness and increase the amount of 

information that is available prior to signing the informed consent document. This opportunity is 

especially important because the informed consent process is too often one that occurs in a 

hurried fashion under intimidating surroundings and confronts the potential subject with a 

detailed, lengthy document to sign — one that often appears aimed more at the legal liability 

concerns of the institution or sponsor than to the concerns of the potential subject.3 Informed 

consent of this kind inhibits the comprehension or voluntariness envisioned in the Belmont 

Report. 

Relevance to Federal Oversight 

Within the Department of Health and Human Services, two components have the primary 

responsibility of helping to ensure the rights and welfare of human subjects participating in 

clinical research. The Food and Drug Administration (FDA) regulates research in the products 

it regulates. The Office for Human Research Protections (OHRP) within the Office of the 

Secretary ensures the rights and welfare of human subjects participating in research funded by 

HHS. Both entities rely heavily on IRBs for ensuring adherence to Federal regulations that 

protect human subjects.4 These boards conduct initial and continuing reviews of research 

protocols, informed consent documents, and recruiting practices. FDA and OHRP issue 

guidance documents to help IRBs, sponsors, and investigators meet the Federal requirements. 

Methodology 

Our inquiry analyzed 22 Web sites and 110 clinical trial listings. The exact number of clinical 

trial Web sites is unknown because of the vast and constantly changing nature of the Internet. 

Therefore, we researched relevant literature and interviewed key stakeholders to select a 

sample of 22 Web sites that is largely made up of third-party sites, but also includes Federal 

sites, location-specific sites, and sponsor-specific sites (see appendix D for a complete listing of 

the 22 Web sites).5 For our review of clinical trial listings, we selected five listings from each of 

the 22 Web sites, for a total of 110. The sample of listings represents various drug trials for 

Clinical Trial Web Sites 2 OEI-01-97-00198 
life-threatening diseases and chronic illnesses. We did not review other practices of Internet 

recruitment such as Web sites that are specific to one trial and banner advertisements. 

We reviewed two types of information from each Web site in our sample: general clinical trial 

information and trial-specific information. We reviewed each of the 22 Web sites for the types 

of general clinical trial information they provide, such as a description of Federal regulations and 

the process of informed consent We reviewed our sample of 110 clinical trial listings for the 

types of trial-specific information they provide such as title, purpose, and contact information. 

We did not evaluate functionality or accuracy of information of the Web sites. (See appendix 

D for all data elements.) 

We conducted interviews with key representatives from 10 of our sample Web sites to answer 

broader questions and provide greater context. Interviews included discussions about the 

advantages and disadvantages of Internet recruitment, Federal guidance, and the role of IRBs. 

In addition, we interviewed Federal officials at OHRP and FDA, IRB members, privacy and 

patient advocates, and ethicists. 

This report reflects the information that these Web sites provided during the period of April 

2001 through September 2001. Since our review of these Web sites, some have changed in 

appearance and content. 

We conducted this study in accordance with the Quality Standards for Inspections issued by 

the President’s Council on Integrity and Efficiency. 

Clinical Trial Web Sites 3 OEI-01-97-00198 
A PRIMER 

CLINICAL 

ON 

TRIAL WEB SITES 

What kind of information do Web sites provide? 

General Clinical Trial Information. This can cover a wide range including, but not limited to, information on 

the elements of clinical trials and the drug approval process such as the protections afforded to human subjects 

participating in trials, the definitions of key medical and research terms, and the standard treatments, therapies, 

and the state of research for particular diseases. 

Trial-Specific Information. Clinical trial listings on these Web sites provide specific information about trials 

enrolling subjects. The information is likely to include the title, purpose, eligibility criteria, and contact 

information. 

What types of Web sites exist? 

Federal Sites. Three such sites are: (1) The AIDS Clinical Trials Information Service (ACTIS) offers a database 

of AIDS clinical trials; (2) CancerNet provides a database of cancer clinical trials, and (3) ClinicalTrials.gov 

presents a listing of all federally and some privately funded clinical research.6 The National Institutes of Health 

maintains these three sites. 

Third-Party Sites. These sites are not operated by funders, sponsors, or by the institutions at which trials are 

being carried out. They tend to be operated by private companies. The information on them is typically 

copyrighted. Most of the trial listings on these sites are copied from Federal sites (in some cases the Web site 

will edit the Federal trial descriptions). Sites also obtain trial information directly from sponsors and clinical 

investigators. In a few instances, sites create their own clinical trial descriptions, drawing on non-copyrighted 

sources. These sites generate revenue in the following ways: (1) fee-per listing (a flat fee to list a single trial); (2) 

fee-per-referral (a fee levied each time an individual contacts the trial location through the site); (3) fee-perenrollment (a fee for each subject that ends up enrolling in a trial ; and (4) fee for data access (a charge to 

outside entities seeking access to the site’s databases that maintain information on individuals who use the 

site); and (5) fee for advertising on the site. 

Location-Specific Sites. A specific healthcare facility or its contractor manages these sites and mainly list 

clinical trials being conducted at their location. Trial information tends to be obtained directly from the clinical 

investigators at those locations. 

Sponsor-Specific Sites. Commercial sponsors of clinical trials or their contractors manage these sites. Trials 

listed on these sites tend to be only those trials supported by the sponsor. Information on the site is provided 

by the sponsor or contractor; the clinical investigators are not necessarily involved with or even aware of this 

process. 

Others. These include sponsor and location-specific sites, as well as patient advocacy sites. 

What Kind of Services do the Web Sites Provide? 

Prescreening. There are two types: General Prescreening for Clinical Trial Listings, an online questionnaire 

used to generate a list of clinical trials an individual may be eligible for, and Prescreening for a Specific Trial, an 

online questionnaire used to determine if an individual is eligible for a particular clinical trial. If the individual is 

eligible, then, depending on the site, the individual or the Web site may contact the clinical investigator to 

discuss enrollment. 

Disease Information. Offers information concerning specific diseases. 

Trial Folders. Enable users to save specific trials of interest and access them later through a password. 

E-Mail Updates. Provide notices that alert users to new trials and information available on the site. 

Message Center. Allows users to access, via a password, messages in areas of particular interest. 

Chat Rooms. Allows users to discuss with one another about various health-related topics. 

Clinical Trial Web Sites 4 OEI-01-97-00198 
FINDINGS 

Web sites are emerging as an important recruitment strategy. 

Clinical trial Web sites are growing in popularity. 

Increasing number and variety of Web sites. Over half of the 22 Web sites we reviewed 

were created in the last 5 years. The Federal government took the lead in using the Internet to 

provide clinical trial information to the public and is still a major player, despite the entrance of 

various privately run Web sites. Entrepreneurs are starting companies focused on recruiting 

human subjects over the Internet. Pharmaceutical companies and contract research 

organizations are listing clinical trials on their own Web sites as well as listing trials on other 

clinical trial Web sites. Research institutions such as academic medical centers are creating 

their own Web sites that list trials currently enrolling subjects at their institution. 

Increasing use of clinical trial Web sites. Total visitors on the National Cancer Institute’s 

Web site, CancerNet, increased steadily during the last year.7 The site averaged about 

500,000 visitors per week in May 2000 and increased to 700,000 visitors per week in May 

2001. Another popular Web site, CenterWatch, saw the average number of visitors increase 

from 38,000 in 1997 to 334,000 in 2000.8 Similarly, the government-sponsored AIDS Clinical 

Trials Information Service, ACTIS, averaged 6,084 visitors per month in 1999. Within 2 years 

this number more than doubled to about 12,580 visitors per month.9 

Research professionals that use the Internet for recruiting patients are also contributing to the 

increase of visitors to these Web sites. According to a recent survey of sponsors and contract 

research organizations conducted by the Association for Clinical Research Professionals, 15 

percent of the respondents regularly use the Internet to recruit patients and by 2001 over half of 

the respondents expect to use the Internet regularly to recruit patients.10 

Three basic trends drive the growth of the number of visitors to clinical trial Web sites. First, 

consumers are taking an increasingly active role in managing their health care. According to a 

recent survey of human subjects, 54 percent self-referred themselves into a trial.11 Second, 

physicians are beginning to incorporate the Internet into their profession. A recent poll showed 

that from 1999 to 2001, physician use of the Internet went up from 34 percent to 40 percent.12 

As physicians become more accustomed to using the Internet, they will likely use it to search 

for clinical trials for their patients as well as encourage their patients to do so on their own. And 

finally, the growing accessability and use of the Internet, in general, is fueling the number of 

visitors to clinical trial Web sites. 

Clinical Trial Web Sites 5 OEI-01-97-00198 
Clinical Trial Web sites offer several benefits as a recruitment vehicle. 

Representatives from clinical trial web sites estimate that these sites enroll between 10-15 

percent of the subjects in a particular trial. They anticipate that the percentage of enrollees from 

the Internet will increase as the sites become more widely used. Below we identify three 

advantages that these sites offer as a recruitment vehicle. 

Accessibility. In the latter half of 2000, over 100 million adults accessed the Internet.13 An 

estimated 60 million people used the Internet to seek health or medical information.14 The Web

sites make clinical trial information accessible to anyone on the Internet. The anonymity that

many of the sites offer may further encourage the use of these Web sites by individuals who

may not have otherwise done so out of concern for privacy or confidentiality. 

Clinical trial Web sites have made information particularly accessible to vulnerable populations

who are often desperate for medical options. Many of these Web sites have taken great strides

to make clinical trial information accessible to those suffering from a chronic or life-threatening

illness such as AIDS or cancer, especially where standard medical treatment has failed. 

“Cancers and other Neoplasms” is the largest disease category on ClinicalTrials.gov offering

2,103 trials out of the 11,000 trials available on the Web site.15 One Web site we reviewed,

EmergingMed, is devoted entirely to cancer trial listings.

Clinical trial Web sites also improve access to clinical trial information for rare diseases. 

Identifying potential subjects for rare disease trials is difficult for sponsors and investigators

since the population is small and the diseases are less known. Individuals with rare diseases

often do not hear about trials, especially if they are far from a large medical center. These Web

sites can provide people all over the country with access to rare disease information and clinical

trial locations. “Rare Diseases” is the second largest disease category on ClinicalTrials.gov with

1,901 trials.16

Personalization. The Internet allows Web

sites to customize the information and services

they provide to individuals (table 1). One of

the most advantageous services is prescreening. 

Many of these Web sites contain hundreds and,

in some cases, thousands of trial listings. 

Prescreening uses personal information that is

submitted by individuals to determine their

eligibility for one or more trials. An effective

prescreening process can quickly bring together

a potential subject and investigator and help

ensure timely enrollments. Other services such

as chat rooms and e-mail updates help keep

individuals abreast of new information as well as offer support.

Table 1. Personalized Services 

Provided by 22 Clinical Trial Web Sites 

Personalized 

Services 

Number of 

Web Sites 

Prescreening 8 

Personal folders 6 

E-mail updates 12 

Chat rooms 2 

Clinical Trial Web Sites 6 OEI-01-97-00198 
Cost effectiveness. On average, recruitment accounts for 10-15 percent of the overall 

research study budget.17 Traditional advertising, print or television, can be one of the more 

expensive recruitment strategies and can cost, on average, over $600 dollars per patient 

enrolled.18 The Internet can disseminate information relatively inexpensively and reduce the 

costs associated with recruiting. One case study estimated Internet recruitment costs at $63 

per enrolled patient — less than half the cost of other recruiting strategies used for the study.19 

Clinical trial Web sites show promise as a means of fostering 

informed consent. 

Most of the 22 Web sites we reviewed provide valuable general clinical trial 

information. 

Below we demonstrate how clinical trial Web sites can help foster informed consent by 

providing key general information to potential subjects. In our review of 22 Web sites we 

found that: 

< 21 explain the importance of informed consent as a means to help subjects make an 

informed decision about whether to participate in a clinical trial. 

< 16 describe the role of IRBs in protecting human subjects. 

< 16 explain the overall purpose of clinical trials is to learn about a new drug or diagnostic 

test, not to treat patients. 

< 12 describe clinical trials as part of the FDA’s drug approval process to evaluate the 

safety and efficacy of drugs. 

< 12 explain the importance of weighing the risks and benefits associated with a clinical 

trial when considering to participate. 

However, these Web sites vary in the extent of information they provide. For example, we 

found one site that describes the role of IRBs in a single sentence, compared with another that 

devotes an entire paragraph to the subject and even elaborates on the importance of IRB 

members avoiding conflicts of interest. 

Clinical Trial Web Sites 7 OEI-01-97-00198 
Figure A: Explaining the Role of IRBs 

Source: thehealthexchange.org (6/25/01) 

Below are two examples we selected from Web sites that demonstrate the promise that these 

sites offer to foster informed consent. One explains the role of IRBs (figure A); the other 

clearly states that trials may have risks as well as possible benefits (figure B). (For more 

examples of promising approaches see appendix B.) 

Figure B: Explaining Risks Associated with Clinical Trials 

Are there risks in clinical trials? 

The process of evaluating new treatments can involve some risk. All drugs used 

in clinical trials have been extensively tested in laboratory experiments. 

However, some side effects do not become apparent until the treatments are 

given to humans. Side effects can vary from patient to patient. It is important to 

remember that clinical trials can carry unknown dangers as well as possible 

benefits. 

Source: Veritas Medicine (3/29/01) 

Clinical Trial Web Sites 8 OEI-01-97-00198 
Most of the 22 Web sites we reviewed provide important trial-specific information. 

In our review of 110 clinical trial listings we found that: 

< 91 (83 percent) provide eligibility criteria. This type of information is important 

because it discourages individuals from inquiring about trials for which they are not 

eligible, thereby, allowing individuals to focus their time on understanding information in 

those trial listings that are most relevant to them. 

< 80 (73 percent) provide a purpose statement. A purpose statement can indicate the 

type of experimental drug being tested, the type of subjects needed, and further 

emphasize that a clinical trial is research, not treatment. 

Similar to general information, the extent of trial-specific information varies from site to site. 

For example, one Web site we reviewed provides several paragraphs of eligibility criteria that 

included sex, disease, age, previous medications and surgical treatments, and stage of disease, 

while another Web site for the same trial only offers sex, age, and disease information. 

We highlight two examples from Web sites that use novel approaches to present clinical trial 

listings in an easy format that fosters comprehension. (For additional examples of promising 

approaches see appendix B.) One provides an interactive listing that links to a glossary of 

terms. Within each listing, selected words are underlined to indicate they are active links to the 

National Cancer Institute’s dictionary of cancer terms (figure C). The other example shows 

how the interactive capability of the Internet can allow individuals to link from the trial listing to 

other sources of information such as relevant journal articles (figure D on following page). 

Figure C: Defining Clinical Trial Terms 

Source: Cancernet (7/16/01) 

Clinical Trial Web Sites 9 OEI-01-97-00198 
Figure D: Providing Background Information on a Clinical Trial 

Source: ClinicalTrials.gov (7/16/01) 

But clinical trial Web sites are not taking full advantage of their 

potential to foster informed consent. 

Most of the clinical trial listings we reviewed exclude key information. 

Web sites provide trial-specific information in listings to draw in those people who may be 

potential study subjects. It is important, especially from the outset, that this information be 

accurate and comprehensive. If not, then potential subjects may enter the informed process 

with false impressions, thereby undermining that process. 

In our review of 110 clinical trial listings, we found that: 

<None describe the risks associated with the study protocol, while 29 describe the benefits to 

subjects. It is important that risks and benefits are presented to subjects in a balanced 

fashion. Listings that only provide benefits can mislead individuals to assume that the trial is 

without risks. We found that most of the benefits described were not therapeutic, but instead 

focused on convenience and incentives to the study subject, such as free parking and 

monetary compensation. These benefits can be misleading if not tempered by a statement that 

risks are involved. 

<77 (70 percent) fail to identify the sponsor for the clinical trial. The name of the sponsor tells 

the individual who is accountable for the study. 

Clinical Trial Web Sites 10 OEI-01-97-00198 
<69 (63 percent) do not indicate the phase of the clinical trial. Thus, in these cases, an 

individual would not be able to distinguish a phase one trial aimed strictly at testing the safety 

of an experimental drug from a phase three trial focused on testing efficacy as well as safety. 

<56 (51 percent) lack a general description of the protocol. A general description provides a 

sense of the procedures that a subject will undergo and the time commitment that is necessary 

to participate in the trial. 

Some clinical trial Web sites we reviewed provide misleading information that can 

undermine informed consent. 

In our prior reports we found traditional advertisements that overstated benefits to recruit 

human subjects.20 Therefore, it is not surprising that we also found this to be a problem on 

several clinical trial Web sites. Below we cite some examples of misleading general information 

that we found on three different Web sites. In each case we explain our basis of concern: 

Example #1 

Web Site Text: “Why should I participate in a clinical trial?...Often [taking part in a 

research study] gives you the chance to access a medicine that is not available on the 

market for prescription.”21 

Basis for Concern: This statement neglects to mention that the medicine has not yet 

been shown to be safe and effective, which is why it is not on the market. 

Example #2 

Web site Text: “Is a clinical trial right for you?...Many people who volunteer for 

studies do so because it provides them access to new drug treatments before they are 

available in the marketplace.”22 

Basis for Concern: Similarly, this statement neglects to mention that the medicine has 

not yet been shown to be safe and effective and that the main objective of clinical trials 

is not about access, but about research. 

Example #3 

Web site Text: “Clinical trial phases...In general, the chances of success in a phase I 

trial are good...”23 

Basis for Concern: Phase one trials are not designed to show efficacy; they are 

designed to show that the drug is not toxic in humans. Little is known about the safety 

Clinical Trial Web Sites 11 OEI-01-97-00198 
of drugs in phase one trials, because this is when they are usually tested in humans for 

the first time or are evaluations of a new dosage or new mode of administration. 

Most clinical trial Web sites we reviewed that collect personal information fail to 

disclose how they will use the information. 

Of the 22 Web sites we reviewed, 13 collect personal information and each of them provide an 

online privacy policy. However, in our review of these 13 online privacy policies we found that: 

<11 do not indicate how long the Web site stores personal information. 

<9 do not address their processes to ensure that personal information is securely submitted 

over the Internet. 

<7 do not specify whether personal information is shared with an investigator or a clinical 

research personnel at the trial location. 

<6 do not provide a linking policy that addresses privacy concerns when users leave their Web 

site and link to a different site. Lack of a linking policy is worrisome because linking from one 

site to another can appear seamless and individuals may be unaware that they have left the 

original site. 

Collecting personal information such as health information is not necessarily inappropriate. In 

fact, many individuals are willing to share such information in return for possible benefits. The 

issue of concern from the perspective of protecting human subjects is whether users are fully 

aware of how their personal information will be used prior to submitting it to the Web site. 

Clinical trial Web sites provide minimal information about their financial 

relationships. 

Of the 12 Web sites that generate revenue, half fail to disclose how they do so. Knowledge of 

a Web site’s financial relationships can affect how an individual interprets information on that 

Web site. Of those Web sites that do disclose their revenue sources, three indicate that they 

generate revenue from patient enrollment/referral fees and three indicate that they generate 

revenue from trial listing fees. Aside from addressing revenue based on patient enrollment and 

listing fees, only one Web site clearly states it does not accept funds from pharmaceutical 

companies and another site states it does not accept advertising. Three Web sites do accept 

advertisements and provide a corresponding advertisement policy. 

Clinical Trial Web Sites 12 OEI-01-97-00198 
IRBs face major challenges in reviewing clinical trial Web sites. 

Institutional review boards (IRBs) are the only entities whose sole function is to ensure humansubject protections.24 They play a critical role in safeguarding subjects’ rights and welfare 

during the recruitment process, informed consent process, and the conduct of the trial. 

Limited Federal guidance on trial-specific information. 

Both FDA and OHRP have issued guidance documents to sponsors, investigators, and IRBs 

regarding recruitment practices. Current FDA guidance addressing clinical trial listings on the 

Internet is part of a broader commentary about recruitment that is addressed in the 1998 FDA 

Information Sheet, “Recruiting Study Subjects.” OHRP’s guidance is contained in its 1993 

Institutional Review Board Guidebook and endorses the aforementioned FDA Information 

Sheet. Because the two guidance documents are identical, we will refer to them together as 

Federal guidance. 

Unclear language determining when a clinical trial listing requires review. Federal 

guidance calls for IRBs to review and approve all direct advertisements to study subjects.25 

However, the guidance carves out an important exemption for clinical listing services. It states 

that clinical trial listing services that contain basic trial information do not need to be reviewed 

by an IRB. It adds that basic trial information includes: title, purpose, protocol summary, basic 

eligibility criteria, study site location, and how to contact the site. The guidance specifically 

mentions the National Cancer Institute’s cancer trial listing, the Physician’s Data Query (PDQ) 

found on CancerNet, and the government-sponsored AIDS information service, ACTIS, as 

examples of clinical trial listing services that contain basic trial information and do not require 

IRB review. 

However, many of the clinical trial Web sites in our review provide additional trial information in 

their listings that is not explicitly mentioned in the guidance as basic trial information, such as 

risks and benefits and the name of the investigator or sponsor. It is unclear whether this type of 

trial-specific information is considered to be basic trial information. If it is not basic trial 

information, then according to current guidance it requires review by an IRB. Although some 

investigators, sponsors, and Web sites submit clinical trial listings for review regardless of 

whether they contain basic trial information, most do not appear to do so. 

Failure to address privacy issues surrounding prescreening for specific trials. 

Prescreening for a specific trial uses a questionnaire that asks individuals to answer personal 

questions to determine whether they are eligible for particular trials (see figure F on the 

following page for sample questions). The personal information collected through prescreening 

raises concerns about privacy and confidentiality. 

Clinical Trial Web Sites 13 OEI-01-97-00198 
Although prescreening through the Internet is new, the concept of prescreening is not. Online 

prescreening questions are similar to those on scripts that are used by telephone receptionists at 

central call centers for determining eligibility for a specific study. Federal guidance has long 

required receptionist scripts to be reviewed by an IRB to ensure that individuals’ confidentiality 

and privacy are protected. However, the guidance does not require online prescreening 

processes, which contain the same type of sensitive questions as receptionists’ scripts, to be 

reviewed by an IRB. 

Figure F: Collecting Sensitive and Private Health Information Through 

Online Prescreening Questionnaires 

Source: Emergingmed.com (7/24/01) 

Limited leverage over general clinical trial information. 

The general information on a clinical trial Web site is of considerable relevance to the informed 

consent process. It can, as we have suggested, help individuals gain valuable perspectives on 

the pros and cons of clinical trials and on the protections that are supposed to be afforded to 

human subjects. As noted earlier, it can also serve as a means of misleading potential subjects 

— for example, by indicating that trials present an opportunity to gain access to new drugs. 

Notwithstanding the significance of the information presented at this general level, it exists in a 

domain that is beyond the purview of IRBs. Federal regulations do not require the IRBs to 

review this information. The limited attention that IRBs give to Internet recruitment is, therefore, 

limited almost entirely to trial-specific information. 

Clinical Trial Web Sites 14 OEI-01-97-00198 
IRBs are overburdened. 

Some IRB members that we spoke with require investigators to submit for review clinical trial 

listings that will be posted on Web sites. They also anticipate more Internet-based recruitment 

in the future and expressed concerns about how to address the increasing use of this strategy. 

In a prior report we drew attention to the fact that IRBs are reviewing more materials at a faster 

pace.26 We also found that 25 percent of IRBs do not even ask investigators to explain their 

recruiting practices.27 

Many IRBs are already burdened by increased workloads and lack the resources to devote to 

reviewing traditional recruitment materials. The nature of the Internet allows for vast amounts of 

information to be published and updated relatively inexpensively. Some trial listings on the Web 

can be four pages long and contain numerous links to other Web sites that provide even more 

information. Thus, clinical trial listings contain more information than a typical print 

advertisement and review of them will likely add to IRB workloads. 

Clinical Trial Web Sites 15 OEI-01-97-00198 
RECOMMENDATIONS 

In this inquiry we focused on the potential that clinical trial Web sites have to foster informed 

consent. Below we recommend steps that can be taken to use this potential and help ensure 

that information on these Web sites does not undermine informed consent. We direct our 

recommendations jointly to the Food and Drug Administration (FDA) and to the Office for 

Human Research Protections (OHRP). We urge FDA and OHRP to work together with 

external stakeholders to address these recommendations. 

Provide further guidance to IRBs on clinical trial Web sites. 

The recent growth of Internet-based recruitment strategies warrants renewed attention in 

guidance. We recommend that FDA and OHRP develop a new section, within current 

guidance, that specifically address recruitment practices on the Internet. In regard to clinical 

trial Web sites, we recommend to FDA and OHRP the following: 

Clarify that risk and benefit information in trial listings is subject to IRB review and 

approval. 

Current guidance does not require IRB review if the clinical trial listing is limited to the following 

basic trial information: title, purpose, of the study, protocol summary, basic eligibility criteria, 

study site location(s), and how to contact the study site for further information.28 This is a 

sound policy that we do not propose to change. However, some Web sites we reviewed 

provide more than the prescribed basic trial information mentioned in current guidance. In 

these instances it is unclear to IRBs whether review of the listing is required. Therefore, we 

recommend FDA and OHRP make it clear that (1) risk and benefit information in a trial 

listing is subject to IRB review and approval, and (2) sponsors and investigators have the 

responsibility to obtain that review. The IRB is the most suitable entity to ensure that risk and 

benefit information is presented in a balanced and fair manner. 

Require IRB review of any prescreening used for specific trials. 

Prescreening for specific trials use questionnaires to ask potential subjects personal and 

sensitive health information to determine their eligibility for those trials. Such screening 

questions should be subject to IRB review and approval. In instances where this information is 

personally identifiable and stored, FDA and OHRP should call for IRBs to review this type of 

prescreening to ensure that appropriate steps have been taken to address privacy issues. 

Guidance should be similar to what is already in place for receptionist scripts that are used at 

central call centers. 

On page 18, we suggest voluntary standards that IRBs may want to consider for privacy 

policies of clinical trial Web sites that collect personal information. 

Clinical Trial Web Sites 16 OEI-01-97-00198 
Facilitate the adoption and use of voluntary standards for clinical 

trial Web sites. 

FDA and OHRP should exert leadership to foster the development and application of voluntary 

standards for clinical trial Web sites. Such standards could address various aspects of these 

sites, such as accuracy, comprehensiveness and functionality. On the basis of our inquiry, we 

have developed a preliminary framework offering four standards that are especially pertinent to 

the role of Web sites in fostering informed consent (see page 18). Developing such standards 

can be an important way of conveying the important role that Web sites can play as 

mechanisms of informed consent and of raising the bar of current practice. The standards we 

propose go beyond the risk-benefit and prescreening information for which we call for 

mandatory IRB review. 

We suggest that FDA and OHRP determine the best ways in which they might exert such 

leadership to facilitate the development and encourage the use of voluntary standards. 

Developing such standards would necessitate a broad public dialogue. Our preliminary 

framework is presented with the intent to help focus discussions on how the Web sites can 

serve as more significant vehicles of informed consent.29 One promising approach to facilitate 

discussion would be to promote public workshops involving key stakeholders such as 

representatives of Web sites, the broader research community (government and industry), and 

patient advocacy organizations. FDA and OHRP could propose points to be considered in 

these workshops. 

Encourage clinical trial Web sites to undergo periodic review by 

independent bodies. 

The conduct of reviews of individual sites by independent parties can be an important step in 

enhancing the credibility of clinical trial Web sites. Such reviews could address the general 

information provided on the sites — an area that currently is excluded from IRB review. They 

could, for example, address privacy policies and procedures to ensure that personal information 

is handled appropriately. These independent reviews could also address trial-specific 

information, perhaps involving an examination of a sample of listings to make sure that they 

provide balanced information about the trials. 

Such independent reviews could be performed by IRBs. On their own initiative, two of the 

Web sites we reviewed have already contracted with IRBs to provide such reviews. The 

reviews could also be performed by an accrediting body. Although not directly geared toward 

human-subject protection issues, several organizations already exist that have developed 

standards for health information Web sites. Four of the Web sites we reviewed are members 

of the Health on the Net Foundation and subscribe to its eight principles (see appendix C for a 

description of these organizations). 

Clinical Trial Web Sites 17 OEI-01-97-00198 
Standards for Clinical Trial Web Sites: 

A Preliminary Framework 

Standards Elements 

General Clinical Trial Information 

Provide a comprehensive 

overview of clinical trials 

The more subjects know 

about the process in general 

the more informed their 

decision to enroll will be. 

A comprehensive overview includes: 

< Clear statement that a clinical trial is research not treatment 

< Description of FDA’s drug approval process 

< Description of the Common Rule and FDA Good Clinical 

Practice regulations 

< Description of the informed consent process 

< Description of the role of IRBs 

< Explanation of the importance of weighing risks and benefits 

< Information on how to contact key Federal agencies for further 

clinical trial information 

< Sources of clinical trial information 

< Explanation of the importance of considering alternatives to a 

clinical trial. 

Disclose prominently a 

comprehensive 

privacy/confidentially policy 

Disclosure gives consumers 

control over their personal 

information before they share 

it. 

aware of how their personal 

information will be used. 

A comprehensive policy contains the following with regards to 

personally identifiable information: 

< How long is personal information retained 

< What information is collected 

< How information will be used 

< What entities or individuals have access 

< How consumers can eliminate personally identifiable 

information 

< When the policy was last updated 

Disclose prominently 

significant financial 

relationships 

Informs the subject of 

potential conflicts of interest 

the Web site may have. 

Significant financial relationships include: 

< Revenues collected based on Web site services 

< Funding the site receives from pharmaceutical companies, 

health insurers, trial sites, etc. 

< Agreements for advertising on the site 

Consumers should be fully 

Trial-Specific Information 

Provide key information in 

clinical trial listings 

Key information about specific 

trials helps the subject more 

quickly identify appropriate 

trials. 

Key trial information includes: 

< Title 

< Phase 

< Purpose 

< Description of trial 

< Eligibility criteria 

< Duration of trial 

< Time commitment for the subject 

< Balanced description of risks and benefits 

< Compensation for injury 

< Name of trial sponsor(s) 

< Name of clinical investigator(s) 

< Contact information for research site(s) - contact name, phone 

number, and location 

SOURCE: Office of Inspector General. 

Clinical Trial Web Sites 18 OEI-01-97-00198 
COMMENTS ON THE DRAFT REPORT 

We received comments on our draft report from the Food and Drug Administration, the Office 

for Human Research Protections, and the National Institutes of Health. Below, we summarize 

the major comments and, in italics, offer our response. We made a number of changes in the 

final report, mostly technical in nature. The full text of each set of comments appears in 

Appendix E. 

Food and Drug Administration 

FDA commended our report and indicated it will work to include our recommendations as it 

reviews its Information Sheets for IRBs and Clinical Investigators. However, FDA expressed 

concern about the potential burdens to the already overburdened IRBs. As a way of easing the 

burden, it suggested that Federal guidance might call for IRBs to limit theirs reviews of trialspecific information to that information not considered basic trial information. 

We modified our recommendations to focus IRB review and approval to the risk and 

benefit information and prescreening questions for trial listings. 

Office for Human Research Protections 

The Office for Human Research Protections describes the report as “comprehensive and 

insightful.” But it takes the position that clinical trial Web sites have not only the potential, but 

also the requirement, to foster informed consent and to meet all provisions of the Federal 

Common Rule. Even basic trial information, it states, is subject to IRB review. If further 

guidance is needed to make this clear, it urges it that it be issued. 

OHRP’s response focuses on institutional Web sites that function under the federal 

assurance process overseen by OHRP. Our review included these sites but also many 

others that are not part of an institutional assurance. We suggest that FDA and OHRP 

work together to produce a common set of expectations for all Web sites. The 

preliminary standards we propose may be helpful in this regard. 

National Institutes of Health 

The National Institutes of Health indicated that it was pleased with the report and offered a 

number of technical clarifications which we addressed in the report. Substantively, NIH was 

not clear if IRB approval of a clinical trial listing at the study site was sufficient or if a separate 

Web approval is needed. 

We have added a clarification in our text that sponsors and investigators are responsible 

for obtaining IRB approval for any clinical trial Web site listing they initiate that goes 

beyond providing basic clinical trial information. 

Clinical Trial Web Sites 19 OEI-01-97-00198 
APPENDIX A 

The Main Players in Clinical Research 

Clinical trials for new drugs are complex and require the engagement of many different entities. 

In recent years, the number of these entities and their agents has proliferated. Below, we 

describe the roles of and interactions among these players. 

Sponsors 

Sponsors are the primary agents responsible for conducting the clinical trial and typically are the 

primary source of funding for the trial. They can be either pharmaceutical companies or Federal 

agencies such as the National Institutes of Health. Sponsors are responsible for conducting onsite oversight of their trials. This oversight is carried out by monitors. Recently, in an attempt to 

reduce their research and development costs and to streamline processes, sponsors have started 

outsourcing many aspects of clinical trials to other entities. Sponsors often delegate a variety of 

specialized functions, such as the organization and management of clinical trials, to contract 

research organizations (CROs) which sometimes, in turn, outsource to other specialized entities. 

Patient recruitment firms, which are public relation firms whose sole mission is recruiting human 

subjects, have emerged in recent years in response to sponsors’ desire for speedy recruitment of 

subjects. 

Investigators 

Sponsors depend upon clinical investigators to actually conduct clinical trials. Investigators often 

rely on their staff to handle the administrative and sometimes much of the clinical work associated 

with clinical trials. Often, investigators will have a point person, or study coordinator who is a 

practitioner (generally a nurse) with the primary responsibility to facilitate the conduct of clinical 

trials. Coordinators may be involved in recruiting and obtaining consent from subjects, as well as 

maintaining the data for the trial. Investigators conduct trials in a variety of different settings. 

Traditionally, they have conducted clinical trials primarily in university hospitals, or academic 

medical centers. Increasingly, research occurs in physicians’ private practices or in dedicated 

research sites, sites exclusively used for research. Some investigators and/or sites have tried to 

accommodate sponsors’ desire for efficient, streamlined trial conduct by forming site networks, 

sometimes referred to as site management organizations (SMOs). 

Human Subjects 

The final, and most critical, players in a clinical trial are the human subjects themselves. Subjects 

may be recruited by an assortment of agents and/or entities: sponsors, contract research 

organizations, clinical investigators, research coordinators, and patient recruitment firms. In 

general, sponsors use healthy subjects to test the safety of a drug in first-in-human trials (phase 1 

trials). They use subjects with the condition they are targeting to test the efficacy of a drug in 

later-stage trials (phase 2 and 3 trials). 

Clinical Trial Web Sites 20 OEI-01-97-00198 
APPENDIX B 

Best Practices of Clinical Trial Web Sites 

Here, we cite examples from Web sites that best demonstrate the potential for informing 

individuals about clinical trials. 

Providing General Clinical Trial Information 

Partnering with other health content providers can be an important way to further inform people 

about clinical trials and new medical therapies. Acurian has partnered with HopkinsHealth to 

provide current disease information. HopkinsHealth is managed by Johns Hopkins Medical 

Institutions, which disseminates consumer health information on various disease topics that are 

written by health care professionals.30 Thus, an individual on Acurian is able to read about the 

latest news on treatment approaches, preventive health care, and drugs in development.31 

Defining Key Terms 

Some Web sites provide a glossary of terms for technical words an individual may commonly 

come across while researching clinical trials. CenterWatch and thehealthexchange both provide 

a comprehensive glossary of clinical research terms in their overview of clinical trials.32,33 For 

example, the glossary explains the Declaration of Helsinki, the Common Rule, and adverse 

events. Instead of providing the glossary in only one location, Emergingmed’s “medical 

dictionary” is accessible from every one of its Web pages (figure A).34 The site integrates the 

National Cancer Institute’s online dictionary to define multiple cancer terms. This is not only 

convenient to users, but it also fosters a better understanding of diseases and clinical trials. 

Figure A: Medical Dictionary 

Source: Emergingmed (7/27/01) 

Clinical Trial Web Sites 21 OEI-01-97-00198 
APPENDIX B 

CancerNet provides an interactive trial description that links to a glossary. Within each trial 

listing, selected words are underlined that are active links to the National Cancer Institute’s 

dictionary of cancer terms (figure B). 

Figure B: Dictionary of Disease Terms 

Providing Disease Information 

When individuals focus their trial search to one disease, clinical trial Web sites often provide 

disease-specific information. Each disease 

category on EmergingMed not only provides 

clinical trial information, but also standard 

disease treatments and therapies in 

development (figure C).35 

Veritas Medicine provides similar disease 

information, but, in addition, prominently 

discloses the names of the physicians who 

write the information and offers a link that 

provides their professional background and 

credentials. Each disease category on Veritas 

Medicine is developed by one of their medical 

directors, who are physician-scientists with an 

expertise in a particular disease category.36 

They provide information about disease and 

Figure C: Disease Information 

Source: Emergingmed (7/28/01) 

Clinical Trial Web Sites 22 OEI-01-97-00198 
APPENDIX B 

standard treatment and investigational 

treatments within their disease category. 

This places accountability on the Web 

site and fosters confidence that the 

information provided is accurate and 

reliable (figure D).37 

ClinicalTrials.gov offers specific disease 

information by providing links to 

MEDLINEplus related topics. 

MEDLINEplus is a repository of health 

Figure D: Source of Information 

Source: Veritasmedicine (7/28/01) 

information from the National Library of Medicine.38 This service provides access to extensive 

medical information about specific diseases and conditions. 

Providing Drug Information 

For drugs involved in AIDS clinical trials that are 

listed on the National Institute of Allergy and 

Infectious Disease database, actis.org, the site 

provides links to the AIDSDRUGS Database. In 

the trial description, an individual “clicks” on the 

underlined drug name and is automatically linked to 

extensive AIDS drug information (figure E).39 Drug 

descriptions include links to relevant articles on 

PubMed and to current and past trials that have 

used the drug. 

Figure E: Drug Information 

Source: ACTIS (7/28/01) 

Describing Systems for Protecting Human Subjects 

Educating individuals about the protections of human subjects in clinical trials is an important 

part of the trial process that fosters informed consent. An explanation of human-subject 

protections includes describing the drug approval process, informed consent and the role of 

IRBs. In their overview of clinical trials, CenterWatch summarizes the protection of human 

subjects through IRB approval and the informed consent process (figure F on following page). 

Clinical Trial Web Sites 23 OEI-01-97-00198 
APPENDIX B 

Figure F: Description of Protections for Human Subjects 

The patient's rights and safety are protected in two important ways. First, any 

physician awarded a research grant by a pharmaceutical company or the NIH must 

obtain approval to conduct the study from an Institutional Review Board. The review 

board, which is usually composed of physicians and lay people, is charged with 

examining the study's protocol to ensure that the patient's rights are protected, and 

that the study does not present an undue or unnecessary risk to the patient. Second, 

anyone participating in a clinical trial in the United States is required to sign an 

"informed consent" form. This form details the nature of the study, the risks involved, 

and what may happen to a patient in the study. The informed consent tells patients 

that they have a right to leave the study at any time. 

Source: CenterWatch (4/10/01) 

CancerTrials, an arm of CancerNet, offers a comprehensive description in a section entirely 

devoted to the “Protections for Participants in Clinical Trials”.40 This section gives simple 

explanations and links to safeguards the government has in place to protect human subjects 

such as the informed consent process and larger systems of Federal protection like the 

Common Rule and the Office for Human Research Protections.41 

Explaining Risks 

Of the Web sites we reviewed, only the National Cancer Institute’s CancerNet Web site 

provides a general discussion in the trial listing about the possible risks associated with 

participating in a cancer trial. Each trial description contains the following explanation that 

addresses therapeutic misconceptions individuals may have about participating in a cancer trial 

(figure G on following page). 

Clinical Trial Web Sites 24 OEI-01-97-00198 
APPENDIX B 

Figure G: Explanation of Risks 

Warning 

The purpose of most clinical trials listed in this database is to test new cancer 

treatments, or new methods of diagnosing, screening for or preventing cancer. 

Because all potentially harmful side effects are not known before a trial is 

conducted, dose and schedule modifications may be required for participants if 

they develop side effects from the treatment or test. The therapy or test described 

in this clinical trial is intended for use by clinical oncologists in carefully structured 

settings, and may not prove to be more effective than standard treatment. A 

responsible investigator associated with this clinical trial should be consulted before 

Providing Additional Assistance 

One-on-one assistance. Individuals 

who need assistance in searching for 

clinical trials on CancerNet have access 

to live online assistance from an 

informational specialist, who will 

answer questions about how to use and 

navigate the Web site. Assistance is 

available in the afternoons five days a 

week (figure H).42 

Other Web sites may offer a toll-free 

number to lend assistance for navigating 

Figure H: Online Assistance 

Source: CancerTrials (6/16/01) 

through their site or registering for a trial. Veritas Medicine offers assistance eight hours a day, 

five days a week.43 

Clinical Trial Web Sites 25 OEI-01-97-00198 
APPENDIX B 

A feedback mechanism is useful to let sites 

know whether they are providing their consumers 

with the services they want. Feedback also 

allows an individual to tell the site what services 

are lacking and what needs improvement. 

Veritas Medicine provides an online feedback 

form and will also respond to comments when 

an e-mail address is provided (figure I). 

Safeguarding Personal Information During 

Prescreening 

Figure I: Feedback Mechanism 

Source: Veritas Medicine (7/28/01) 

Recruitment Web site privacy policies are particularly important to the consumer when the site 

provides a prescreening service and collects personal health information. Two Web sites we 

reviewed automatically display a window that discloses to the consumer their intent to collect 

personal health information through a questionnaire. At the end of a trial description, for those 

trials that offer the option to prescreen online, Hopelink provides a “Participation 

Questionnaire”. Prior to the questionnaire, Hopelink provides a web page that describes the 

purpose and process of the questionnaire. In order to proceed to the questionnaire, individuals 

must agree to transfer their contact information to the trial investigative site and click “Agree” 

(figure J is a portion of the prescreening agreement). 

Figure J: Prescreening Agreement 

Source: Hopelink (6/5/01) 

Clinical Trial Web Sites 26 OEI-01-97-00198 
APPENDIX C 

Health Internet Organizations 

The organizations below represent the self-regulatory efforts of the Internet health industry to 

provide credible and reliable health information to consumers. Membership is open to all Web 

sites that provide health information. 

Health on the Net Foundation 

The Health on the Net Foundation (HON) is an international initiative whose 

mission is to “guide lay persons or non-medical users and medical 

practitioners to useful and reliable online medical and health information”. In 

1996, the Foundation established a code of conduct, the HONcode, that 

consists of eight principles of reliable health information on the Internet. 

Membership is free. A Web site fills out a questionnaire to verify that it 

follows HONcode principles and, if not, the steps it will take to comply. 

The Web site then receives the HTML code for the seal to post on the Web 

site. Below are the eight principles.44 

1. Authority. Any medical or health advice provided and hosted on this site will only be 

given by medically trained and qualified professionals unless a clear statement is made that 

a piece of advice offered is from a non-medically qualified individual or organization. 

2. Complementarity. The information provided on this site is designed to support, not 

replace, the relationship that exists between a patient/site visitor and his/her existing 

physician. 

3. Confidentiality. Confidentiality of data relating to individual patients and visitors to a 

medical/health Web site, including their identity, is respected by this Web site. The Web 

site owners undertake to honor or exceed the legal requirements of medical/health 

information privacy that apply in the country and state where the Web site and mirror sites 

are located. 

4. Attribution. Where appropriate, information contained on this site will be supported by 

clear references to source data and, where possible, have specific HTML links to that 

data. The date when a clinical page was last modified will be clearly displayed (e.g. at the 

bottom of the page). 

5. Justifiability. Any claims relating to the benefits/performance of a specific treatment, 

commercial product or service will be supported by appropriate, balanced evidence in the 

manner outlined above in Principle 4. 

Clinical Trial Web Sites 27 OEI-01-97-00198 
APPENDIX C 

6. Transparency of authorship. The designers of this Web site will seek to provide 

information in the clearest possible manner and provide contact addresses for visitors that 

seek further information or support. The Webmaster will display his/her E-mail address 

clearly throughout the Web site. 

7. Transparency of sponsorship. Support for this Web site will be clearly identified, 

including the identities of commercial and non-commercial organizations that have 

contributed funding, services or material for the site. 

8. Honesty in advertising & editorial policy. If advertising is a source of funding it will be 

clearly stated. A brief description of the advertising policy adopted by the Web site 

owners will be displayed on the site. Advertising and other promotional material will be 

presented to viewers in a manner and context that facilitates differentiation between it and 

the original material created by the institution operating the site. 

Hi-Ethics 

Hi-Ethics is a consortium of several health Web sites. The goal of the organization is “to earn 

the consumer's trust and confidence in Internet health services”. Web sites pay an annual fee 

for membership. Hi-Ethics is developing a new program with TRUSTe (see next description) 

due out in 2001. Hi-Ethics established 14 ethical standards to ensure Web sites provide 

reliable and current health information and safeguard confidentiality and security of personal 

information. Below is a brief description of each of the 14 standards:45 

1. Privacy Policies- Disclose use of 

aggregate and personal health 

information. 

2. Enhanced Privacy Protection for 

Health-Related Personal InformationDisclose use of personal health 

information. 

3. Safeguarding Consumer Privacy 

in Relationships with Third PartiesDisclose third party use and access 

to person health information. 

4. Disclosure of Ownership and Financial 

Sponsorship- Disclose major financial 

interests in the Web site or its partners. 

5. Identifying Advertising and Health Information 

Content Sponsored by Third Parties- Disclose how 

the Web site accepts advertising and obtains health 

information, clearly distinguish advertising from 

health information, and disclose significant 

relationships between commercial sponsors and 

health content. 

6. Promotional Offer, Rebates, and Free Items or 

Services- Will comply with Federal and state laws 

regarding these services offered by the Web site 

7. Quality of Health Information Content- The Web 

site will not provide false or misleading health 

information or advertising 

Clinical Trial Web Sites 28 OEI-01-97-00198 
APPENDIX C 

8. Authorship- Disclose source of health 

information and provide a conflict of interest 

policy for all authors. Any information 

created by the Web site will disclose the date 

it was created or last updated. 

9. Disclosure of Source and Validation for 

Self-Assessment Tools- Disclose the source 

and scientific basis for their use. 

10. Professionalism- Maintain and adhere to 

professional ethical principles. 

11. Qualifications- Provide credentials and 

qualifications of those persons supplying 

health information to the Web site and 

disclose if the information is verified. 

TRUSTe 

12. Transparency of Interactions, Candor and

Trustworthiness- Inform consumers of the risks,

responsibilities, and reasonable expectations

associated with using the Web site. The Web site

will

make apparent to consumers when they are moving

from one site to another that may involve a change in

the assumed risks, responsibilities, and expectations

of

the site.

13. Disclosure of Limitations- Disclose the

limitations

of the health information provided on the Web site

and emphasize that the services provided are not

intended to take the place of the health professionalpatient relationship.

14. Mechanism for Consumer Feedback- Make it

easy

for consumers to provide feedback or complaints. 

TRUSTe is an online privacy seal program that assures 

consumers that Web site members adhere to their privacy 

principles. All Web sites that display the seal must disclose their 

personal information collection and privacy practices. Disclosure 

gives Internet users assurance of privacy and choice over how 

their personal information is collected, used, and shared by Web 

sites.46 

Utilization Review Accreditation Commission (URAC) 

URAC, is an organization that has created a health Web site accreditation program. In 

collaboration with Hi-Ethics, URAC’s accreditation program incorporates the 14 Hi-Ethics 

standards. Accredited members display the URAC seal on their site. Accreditation includes a 

fee, an initial audit, and random inspections.47 The final standards were approved by URAC on 

July 27, 2001. 

Clinical Trial Web Sites 29 OEI-01-97-00198 
APPENDIX C 

Internet Healthcare Coalition 

The Internet Healthcare Coalition aims to promote ethical principles within the Internet health 

industry. The coalition is comprised of representatives from the industry, government, 

medicine, law, and patient and consumer groups. In May 2000, the coalition released the final 

draft of their code of ethics meant to be used by Web sites providing health information. The 

code addresses eight principles:48 

1. Disclose information that if 

known by consumers would likely 

affect consumers’ understanding or 

use of the site or purchase or use of 

a product or service. 

2. Be truthful and not deceptive. 

3. Provide health information that 

is accurate, easy to understand, 

and up to date. Also, provide the 

information users need to make 

their own judgments about the 

health information, products, or 

services provided by the site. 

4. Respect users’ right to determine whether or how 

their personal data may be collected, used, or shared. 

5. Respect the obligation to protect users’ privacy. 

6. Respect fundamental ethical obligations to 

patients and clients. Also, inform and educate 

patients and clients about the limitations of online 

health care. 

7. Ensure that organizations and Web sites with 

which they affiliate are trustworthy. 

8. Provide meaningful opportunity for users to give 

feedback to the site. Also, Web sites will monitor 

their compliance with the eHealth Code of Ethics. 

Clinical Trial Web Sites 30 OEI-01-97-00198 
APPENDIX D 

Clinical Trial Web Sites 31 OEI-01-97-00198

Table 1: 

Federal Web 

Sites 

<  actis.org 

<  cancernet.nci.nih.gov 

<  clinicaltrials.gov 

Third-Party 

Web Sites 

<  acurian.com 

<  americasdoctor.com 

<  centerwatch.com 

<  clinicaltrials.com 

<  drugmonitor.com* 

<  drugstudycentral.com 

<  emergingmed.com 

<  trialpages.com 

<  veritasmedicine.com 

<  thehealthexhange.org 

<  hopelink.com 

<  mycure.com 

LocationSpecific Web 

Sites 

<  clinicaltrials.iupi.edu 

<  crnet.mgh.harvard.edu 

<  mayo.edu/research/clinical_trials.html 

<  med.umich.edu/gcrc 

SponsorSpecific Web 

Sites 

<  amgentrials.com 

<  icsltd.net/clinicalstudies 

<  glaxowellcome.com/clinicaltrials_external/c 

linicaltrials.html 

*drugMonitor.com is no longer in operation. 

Source: OIG Data Analysis 

Summary Data of Web Site Review 

The table below presents all the 22 Web sites contained in our review. 

The 22 Web Sites Reviewed 
APPENDIX D 

Clinical Trial Web Sites 32 OEI-01-97-00198

The table below represents elements used to score each of the 22 Web sites. 

Table 2: Review of 22 Clinical trial Web sites 

General Element Yes No NA 

Offers a membership service 13 9 0 

Membership required in order to search for trials 1 11 10 

Membership required in order to obtain contact information 6 6 10 

Describes FDA's drug approval process 12 10 0 

Describes the Common Rule 2 20 0 

Describes the role of IRBs 16 6 0 

Describes the informed consent process 21 1 0 

Discusses the importance of weighing the risks and benefits 12 10 0 

Provides links to Federal Web sites for more information 14 8 0 

Provides a clear statement that clinical trials are research, not treatment 16 6 0 

Discloses payments it receives 6 6 10 

Discloses who is responsible for content 3 19 0 

Accepts advertisements 3 19 0 

Discloses its policy for advertisements 3 19 0 

Member of e-ethics organization 4 18 0 

Provides an online privacy policy 17 5 0 

Collects personally identifiable information 13 9 0 

Discloses how long personally identifiable information is retained 2 11 9 

Discloses that personally identifiable information can be deleted or edited 8 5 9 

Discloses the processes it has in place to secure provided info in transit 4 9 9 

Discloses it policy to notify users of changes in its privacy policy 5 8 9 

Source: OIG Data Analysis 
APPENDIX D 

Clinical Trial Web Sites 33 OEI-01-97-00198

The table below represents elements used to score each of the five specific clinical trials on 

each of the 22 Web sites, for a total of 110 clinical trials. 

Table 3: Review of 110 Clinical Trials on 22 Clinical trial Web sites 

Trial Specific Elements Yes No NA 

Provides a title for the trial 58 52 0 

Indicates the phase of the trial 38 69 3 

Indicates the purpose of the trial 80 30 0 

Provides eligibility criteria 91 19 0 

Provides a general description of the protocol 54 56 0 

Indicates the time commitment required 48 62 0 

Describes of risks associated with trial 0 110 0 

Describes of benefits associated with trial 29 81 0 

Provides sponsor’s name 23 77 10 

Provides investigator’s name 47 63 0 

Provides contact information at the trial site 84 6 20 

Provides disease treatment information 11 99 0 

Source: OIG Data Analysis 
APPENDIX E 

Clinical Trial Web Sites 34 OEI-01-97-00198 
APPENDIX E 

Clinical Trial Web Sites 35 OEI-01-97-00198 
APPENDIX E 

Clinical Trial Web Sites 36 OEI-01-97-00198 
APPENDIX E 

Clinical Trial Web Sites 37 OEI-01-97-00198 
APPENDIX E 

Clinical Trial Web Sites 38 OEI-01-97-00198 
APPENDIX E 

Clinical Trial Web Sites 39 OEI-01-97-00198 
APPENDIX F 

Endnotes 

1. Diana L. Anderson, A Guide to Patient Recruitment (Massachusetts: CenterWatch, 2001), 25. 

2. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects 

of Research. (Washington, D.C.: U.S. Government Printing Office, 1978) DHEW Publication No. 

(OS) 78-0012. Reprinted in Federal Register 44 (April 18, 1979):23192. 

3. We mention these concerns in two prior reports: (1) U.S. Department of Health and Human 

Services, Office of Inspector General, Institutional Review Boards: A Time for Reform, OEI-01-97-

00193, June 1998 and (2) U.S. Department of Health and Human Services, Office of Inspector 

General, Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (OEI01-97-00195), June 2000. 

4. 21 CFR § 50 & 56 and 45 CFR § 46. 

5. We recognize that some Web sites view themselves as educational resources rather than recruitment 

vehicles. We believe this reflects a limited view of recruitment. Any information that is provided to 

subjects with the intent of informing them about specific clinical trials that are actively enrolling is 

recruitment. Recruitment is not contingent on whether or not the entity providing the information 

financially benefits from subjects that actually enroll. 

6. ClinicalTrials.gov was developed as a result of the FDA Modernization Act on 1997. Section 113 

requires Department of Health and Human Services, through NIH, to establish a registry of clinical trials 

for both federally and privately funded trials of experimental treatments for serious or life-threatening 

diseases or conditions. About ClinicalTrials.gov; [ http://www,clinicaltrails.gov, accessed April 19, 2001]. 

Available to industry are guidance documents entitled “Information Program on Clinical Trials for 

Serious or Life-Threatening Diseases or Conditions”, which provide information to industry on the 

submission of protocol information to the clinical trials databank. 67 Fed. Reg. (No.52), 18 March 

2002. 

7. “Total visitors” includes the number of unique visitors and repeat visitors. 

8. Diana L. Anderson, A Guide to Patient Recruitment (Massachusetts: CenterWatch, 2001), 25. 

9. A “user session” is the period from which a individual enters and browses a Web site to the time the 

individual leaves the site. 

Clinical Trial Web Sites 40 OEI-01-97-00198 
APPENDIX F 

10. Diana L. Anderson, A Guide to Patient Recruitment (Massachusetts: CenterWatch, 2001), 177. 

11. Ken Getz, “Patient Experience in Industry-Sponsored Clinical Trials,” presented at the Institute of 

Medicine’s Clinical Research Roundtable, September 2000, Washington, DC. 

[http://www4.nationalacademies.org/IOM/iomhome.nsf/18ace18eb695f74c85256691007102f5/583d8f1384e9e858852569 

bc00511d59?OpenDocument, downloaded on June 20, 2001]. 

12. “New Data Show Internet Website and Email Usage by Physicians All Increasing,” Harris 

Interactive. Volume 1 (February 26, 2001) Issue 8. 

13. “More online, doing more,” The Pew Internet Project: Internet Tracking Report, February 18, 

2001; [http://www.pewtrusts.com/pdf/vf_pew_internet_population_report.pdf, accessed on July 17, 2001]. 

14. Ibid. 

15. http://www.clinicaltrials.gov/ct/gui/c/w2b/screen/BrowseAny?recruiting=true&path=%2Fbrowse%2 

Fby-condition%2Fhier&JServSessionIdzone_ct=zwrpyg7n71, accessed on July 30, 2001. 

16. Ibid. 

17. Harper, B. and Moench, L. “Emerging Patient Recruitment Performance and Cost Metrics” 

Parexels’s Pharmaceutical R& D Statistical Sourcebook, 2000, p. 104. 

18. “A Look at Advertising Expenses Per Patient Recruited,” Parexels’s Pharmaceutical R& D 

Statistical Sourcebook, 2000, p. 103. 

19. Diana L. Anderson, A Guide to Patient Recruitment (Massachusetts: CenterWatch, 2001), 178. 

20. U.S. Department of Health and Human Services, Office of Inspector General, Recruiting Human 

Subjects: Pressures in Industry-Sponsored Research, OEI-01-97-00195, June 2000. 

21. http://www.clinicaltrials.com, accessed on June 11, 2001. 

22. http://www.drugstudycentral.com, accessed on June 22, 2001. 

23. http://www.emergingmed.com, accessed on April 4, 2001. 

24. Sponsors and investigators also play a critical role in ensuring human-subject protections but they 

are also responsible for conducting the research. 

Clinical Trial Web Sites 41 OEI-01-97-00198 
APPENDIX F 

25. FDA’s Information Sheets. Guidance for Institutional Review Boards and Clinical 

Investigators 1998 Update. http://www.fda.gov/oc/ohrt/irbs/toc4.html, accessed on July 17, 2001. 

26. In a prior report we found that IRBs are overburdened because workloads have increased while 

staffing levels and budgets have remained the same. U.S. Department of Health and Human Services, 

Office of Inspector General, Institutional Review Boards: A Time for Reform, OEI-01-97-00193, 

June 1998. 

27. U.S. Department of Health and Human Services, Office of Inspector General, Recruiting Human 

Subjects: Pressures in Industry-Sponsored Clinical Research (OEI-01-97-00195), June 2000. 

28. FDA’s Information Sheets. Recruiting Study Subjects. September 1998, p.29. 

29. In June 2001, FDA issued draft guidance for industry on trial-specific information that should be 

included in clinical trial listings submitted to ClinicalTrials.gov. FDA and OHRP can use this draft 

guidance to facilitate discussions for voluntary standards addressing the trial-specific information that 

should be provided on clinical trial Web sites. 

30. http://www.acurian.com/diseases/bridge_features.jsp, accessed on July 17, 2001. 

31. A Web site “homepage” is defined as the Web page that is displayed and viewed when a user 

initially visits a particular site. 

32. Accessed on July 27, 2001 at [http://centerwatch.com/patient/glossary.html] 

33. http://thehealthexchange.org, accessed on July 27, 2001. 

34. http://emergingmed.com, accessed on July 27, 2001. 

35. http://www.emerginmed.com, accessed on July 28, 2001. 

36. http://www.veritasmedicine.com/fm/about_us/about.cfm?mode=5/, accessed on July 28, 2001. 

37. http://www.veritasmedicine.com/d_index.cfm, accessed on July 28, 2001. 

38. http://www.nlm.nih.gov/medlineplus/, accessed on July 28, 2001. 

39. http://www.actis.org. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form 

of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen, accessed on July 28, 2001. 

Clinical Trial Web Sites 42 OEI-01-97-00198 
APPENDIX F 

40. http://cancertrials.nci.nih.gov/understanding/index.html, accessed on June 7, 2001.

41. http://cancertrials.nci.nih.gov/understanding/indepth/protections/consent/pt01bgd.htm, accessed on

June 19, 2001.

42. http://cancertrials.nci.nih.gov/understanding/index.html, accessed on June 16, 2001.

43. http://veritasmedicine.com, accessed on July 28, 2001.

44. More information on the Health on the Net Foundation is available at www.hon.ch/.

45. More information on Hi-Ethics is available at www.hiethics.com.

46. More information about TRUSTe is available at www.truste.org.

47. More information about URAC is available at www.urac.org.

48. More information about the Internet Healthcare Coalition is available at www.ihealthcoalition.org. 

Clinical Trial Web Sites 43 OEI-01-97-00198 
ACKNOWLEDGMENTS 

This report was prepared under the direction of Mark. R. Yessian, Ph.D., Regional Inspector General 

for Evaluation and Inspections in Boston and Joyce M. Greenleaf, M.B.A., Assistant Regional 

Inspector General. Other principal Office of Evaluation and Inspections staff who contributed include: 

China D. Eng, Program Analyst Genevieve Nowolinski, Program Specialist

Steven P. Keenan, Program Analyst

Aimee K. Golbitz, Program Analyst

Clinical Trial Web Sites 44 OEI-01-97-00198