Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
CLINICAL TRIAL WEB SITES 
A Promising Tool to 
Foster Informed Consent 
JANET REHNQUIST 
INSPECTOR GENERAL 
MAY 2002 
OEI-01-97-00198  O I G
FFICE OF  NSPECTOR  ENERAL

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 OIGs 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.  E X E C U T I V E   S U M M A R Y  
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 Sponsored-
Clinical 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 
Institutes 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. 
i 
Clinical Trial Web Sites  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 trials 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. 
ii 
Clinical Trial Web Sites  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 sites 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. 
iii 
Clinical Trial Web Sites  OEI-01-97-00198  Standards for Clinical Trial Web Sites: 
A Preliminary Framework 
Standards  Elements 
Provide a comprehensive  A comprehensive overview includes: 
overview of clinical trials  <  Clear statement that a clinical trial is research not treatment 
<  Description of FDAs drug approval process 
The more subjects know  <  Description of the Common Rule and FDA Good Clinical 
about the process in general  Practice regulations 
the more informed their  <  Description of the informed consent process 
decision to enroll will be. 
<  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 
on  <  Sources of clinical trial information 
ati <  Explanation of the importance of considering alternatives to a 
m
clinical trial. 
r
o
nf
al I Disclose prominently a  A comprehensive policy contains the following with regards to 
ri comprehensive  personally identifiable information: 
T
al  privacy/confidentially policy  <  How long is personal information retained 
c
ni <  What information is collected 
Cli Disclosure gives consumers  <  How information will be used 
al  control over their personal  <  What entities or individuals have access 
ener iint.f oCrmonastiuomn ebresf osrheo tuhledy b seh faurlely   <  How consumers can eliminate personally identifiable 
G aware of how their personal  information 
information will be used.  <  When the policy was last updated 
Disclose prominently  Significant financial relationships include: 
significant financial  <  Revenues collected based on Web site services 
relationships  <  Funding the site receives from pharmaceutical companies, 
health insurers, trial sites, etc. 
Informs the subject of  <  Agreements for advertising on the site 
potential conflicts of interest 
the Web site may have. 
Provide key information in  Key trial information includes: 
clinical trial listings  <  Title 
<  Phase 
on  Key information about specific  <  Purpose 
ati trials helps the subject more  <  Description of trial 
m quickly identify appropriate 
or trials.  <  Eligibility criteria 
nf <  Duration of trial 
c I <  Time commitment for the subject 
cifi <  Balanced description of risks and benefits 
e
p <  Compensation for injury 
S
al- <  Name of trial sponsor(s) 
Tri <  Name of clinical investigator(s) 
<  Contact information for research site(s) - contact name, phone 
number, and location 
SOURCE: Office of Inspector General. 
iv 
Clinical Trial Web Sites  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. 
OHRPs 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 IRBs 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. 
v 
Clinical Trial Web Sites  OEI-01-97-00198  T A B L E   O F   C O N T E N T S  
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

vi 
Clinical Trial Web Sites  OEI-01-97-00198  I N T R O D U C T I O N  
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 
1 
Clinical Trial Web Sites  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 trial-
specific 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 
2 
Clinical Trial Web Sites  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 Presidents Council on Integrity and Efficiency. 
3 
Clinical Trial Web Sites  OEI-01-97-00198  A  P R I M E R   O N  
C L I N I C A L   T R I A L   W E B   S I T E S  
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-per-
enrollment (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 sites 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. 
4 
Clinical Trial Web Sites  OEI-01-97-00198  F I N D I N G S  
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 Institutes 
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. 
5 
Clinical Trial Web Sites  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
 Table 1. Personalized Services 
they provide to individuals (table 1). One of
 Provided by 22 Clinical Trial Web Sites 
the most advantageous services is prescreening. 

Personalized  Number of 
Many of these Web sites contain hundreds and,
 Services  Web Sites 
in some cases, thousands of trial listings. 

Prescreening  8 
Prescreening uses personal information that is

submitted by individuals to determine their
 Personal folders  6 
eligibility for one or more trials.  An effective

E-mail updates  12 
prescreening process can quickly bring together

a potential subject and investigator and help
 Chat rooms  2 
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.

6 
Clinical Trial Web Sites  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 FDAs 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. 
7 
Clinical Trial Web Sites  OEI-01-97-00198  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 A: Explaining the Role of IRBs 
Source: thehealthexchange.org (6/25/01) 
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) 
8 
Clinical Trial Web Sites  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 Institutes 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) 
9 
Clinical Trial Web Sites  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. 
10 
Clinical Trial Web Sites  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 
11 
Clinical Trial Web Sites  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 sites 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. 
12 
Clinical Trial Web Sites  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 human-
subject 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.  OHRPs 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 Institutes cancer trial listing, the Physicians 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. 
13 
Clinical Trial Web Sites  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. 
14 
Clinical Trial Web Sites  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. 
15 
Clinical Trial Web Sites  OEI-01-97-00198  R E C O M M E N D A T I O N S  
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. 
16 
Clinical Trial Web Sites  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). 
17 
Clinical Trial Web Sites  OEI-01-97-00198  Standards for Clinical Trial Web Sites: 
A Preliminary Framework 
Standards  Elements 
Provide a comprehensive  A comprehensive overview includes: 
overview of clinical trials  <  Clear statement that a clinical trial is research not treatment 
<  Description of FDAs drug approval process 
The more subjects know  <  Description of the Common Rule and FDA Good Clinical 
about the process in general  Practice regulations 
the more informed their 
<  Description of the informed consent process 
decision to enroll will be. 
<  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 
n  <  Explanation of the importance of considering alternatives to a 
o
ati clinical trial. 
m
r
o
nf Disclose prominently a  A comprehensive policy contains the following with regards to 
rial I cporimvapcrye/hceonnfsiidveen tially policy  <pe rsHoonwa llloyn idge isn tpifeiarbsloen ianlf oinrfmoramtioanti:o n retained 
T
al  <  What information is collected 
nic Disclosure gives consumers  <  How information will be used 
Cli control over their personal  <  What entities or individuals have access 
al  information before they share  <  How consumers can eliminate personally identifiable 
r it. Consumers should be fully 
e information 
n aware of how their personal 
Ge information will be used.  <  When the policy was last updated 
Disclose prominently  Significant financial relationships include: 
significant financial  <  Revenues collected based on Web site services 
relationships 
<  Funding the site receives from pharmaceutical companies, 
health insurers, trial sites, etc. 
Informs the subject of  <  Agreements for advertising on the site 
potential conflicts of interest 
the Web site may have. 
Provide key information in  Key trial information includes: 
clinical trial listings  <  Title 
<  Phase 
on  Key information about specific  <  Purpose 
ati trials helps the subject more  <  Description of trial 
m quickly identify appropriate 
or trials.  <  Eligibility criteria 
nf <  Duration of trial 
c I <  Time commitment for the subject 
cifi <  Balanced description of risks and benefits 
e
p <  Compensation for injury 
S
al- <  Name of trial sponsor(s) 
Tri <  Name of clinical investigator(s) 
<  Contact information for research site(s) - contact name, phone 
number, and location 
SOURCE: Office of Inspector General. 
18 
Clinical Trial Web Sites  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 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 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. 
OHRPs 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. 
19 
Clinical Trial Web Sites  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 on-
site 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). 
20 
Clinical Trial Web Sites  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, Emergingmeds medical 
dictionary is accessible from every one of its Web pages (figure A).34 The site integrates the 
National Cancer Institutes 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) 
21 
Clinical Trial Web Sites  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 Institutes 
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  Figure C: Disease Information 
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 
Source: Emergingmed (7/28/01) 
They provide information about disease and 
22 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX B 
standard treatment and investigational 
treatments within their disease category. 
Figure D: Source of Information 
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  Source: Veritasmedicine (7/28/01) 
MEDLINEplus related topics. 
MEDLINEplus is a repository of health 
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 
Figure E: Drug Information 
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. 
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). 
23 
Clinical Trial Web Sites  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 Institutes 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). 
24 
Clinical Trial Web Sites  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  Figure H: Online Assistance 
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 
Source: CancerTrials (6/16/01) 
Other Web sites may offer a toll-free 
number to lend assistance for navigating 
through their site or registering for a trial.  Veritas Medicine offers assistance eight hours a day, 
five days a week.43 
25 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX B 
A feedback mechanism is useful to let sites 
know whether they are providing their consumers 
Figure I: Feedback Mechanism 
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). 
Source: Veritas Medicine (7/28/01) 
Safeguarding Personal Information During 
Prescreening 
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) 
26 
Clinical Trial Web Sites  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. 
27 
Clinical Trial Web Sites  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  5. Identifying Advertising and Health Information 
aggregate and personal health  Content Sponsored by Third Parties- Disclose how 
information.  the Web site accepts advertising and obtains health 
information, clearly distinguish advertising from 
health information, and disclose significant 
2. Enhanced Privacy Protection for 
relationships between commercial sponsors and 
Health-Related Personal Information-
health content. 
Disclose use of personal health 
information. 
6. Promotional Offer, Rebates, and Free Items or 
3. Safeguarding Consumer Privacy  Services- Will comply with Federal and state laws 
regarding these services offered by the Web site 
in Relationships with Third Parties-
Disclose third party use and access 
to person health information.  7. Quality of Health Information Content- The Web 
site will not provide false or misleading health 
information or advertising 
4. Disclosure of Ownership and Financial 
Sponsorship- Disclose major financial 
interests in the Web site or its partners. 
28 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX C 
8. Authorship- Disclose source of health  12. Transparency of Interactions, Candor and

information and provide a conflict of interest  Trustworthiness- Inform consumers of the risks,

policy for all  authors. Any information  responsibilities, and reasonable expectations

created by the Web site will disclose the date  associated with using the Web site. The Web site

it was created or last updated.  will

make apparent to consumers when they are moving

from one site to another that may involve a change in

9. Disclosure of Source and Validation for 
the assumed risks, responsibilities, and expectations

Self-Assessment Tools- Disclose the source 
of

and scientific basis for their use. 
the site.

10. Professionalism- Maintain and adhere to 
13. Disclosure of Limitations- Disclose the

professional ethical principles. 
limitations

of the health information provided on the Web site

11. Qualifications- Provide credentials and 
and emphasize that the services provided are not

qualifications of those persons supplying  intended to take the place of the health professional-

health information to the Web site and 
patient relationship.

disclose if the information is verified. 
14. Mechanism for Consumer Feedback- Make it

easy

for consumers to provide feedback or complaints. 

TRUSTe 
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, URACs 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. 
29 
Clinical Trial Web Sites  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  4. Respect users right to determine whether or how 
known by consumers would likely  their personal data may be collected, used, or shared. 
affect consumers understanding or 
use of the site or purchase or use of 
5. Respect the obligation to protect users privacy. 
a product or service. 
6. Respect fundamental ethical obligations to 
2. Be truthful and not deceptive. 
patients and clients. Also, inform and educate 
patients and clients about the limitations of online 
3. Provide health information that  health care. 
is accurate, easy to understand, 
and up to date. Also, provide the 
7. Ensure that organizations and Web sites with 
information users need to make 
which they affiliate are trustworthy. 
their own judgments about the 
health information, products, or 
services provided by the site.  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. 
30 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX D 
Summary Data of Web Site Review 
The table below presents all the 22 Web sites contained in our review. 
Table 1:  The 22 Web Sites Reviewed 
Federal Web  <  actis.org 
Sites  <  cancernet.nci.nih.gov 
<  clinicaltrials.gov 
Third-Party  <  acurian.com 
Web Sites  <  americasdoctor.com 
<  centerwatch.com 
<  clinicaltrials.com 
<  drugmonitor.com* 
<  drugstudycentral.com 
<  emergingmed.com 
<  trialpages.com 
<  veritasmedicine.com 
<  thehealthexhange.org 
<  hopelink.com 
<  mycure.com 
Location- <  clinicaltrials.iupi.edu 
Specific Web  <  crnet.mgh.harvard.edu 
Sites  <  mayo.edu/research/clinical_trials.html 
<  med.umich.edu/gcrc 
Sponsor- <  amgentrials.com 
Specific Web  <  icsltd.net/clinicalstudies 
Sites  <  glaxowellcome.com/clinicaltrials_external/c 
linicaltrials.html 
*drugMonitor.com is no longer in operation. 
Source: OIG Data Analysis 
31 
Clinical Trial Web Sites  OEI-01-97-00198 APPENDIX D 
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 
32 
Clinical Trial Web Sites  OEI-01-97-00198 APPENDIX D 
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 sponsors name  23  77  10 
Provides investigators 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 
33 
Clinical Trial Web Sites  OEI-01-97-00198 APPENDIX E 
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Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX E 
35 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX E 
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Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX E 
37 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX E 
38 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX E 
39 
Clinical Trial Web Sites  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 (OEI-
01-97-00195), 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. 
40 
Clinical Trial Web Sites  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 
Medicines 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 
Parexelss Pharmaceutical R& D Statistical Sourcebook, 2000, p. 104. 
18. A Look at Advertising Expenses Per Patient Recruited, Parexelss 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. 
41 
Clinical Trial Web Sites  OEI-01-97-00198  APPENDIX F 
25.  FDAs 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.  FDAs 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. 
42 
Clinical Trial Web Sites  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. 

43 
Clinical Trial Web Sites  OEI-01-97-00198  A C K N O W L E D G M E N T S  
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

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