Report and Recommendations 

of the 

Clinical Trials Network Work Group
A National Resource for Communities Taking Action Against Substance Abuse and Gun Violence

David L. Rosenbloom

Director

Janice Ford Griffin

Deputy Director

December 5, 2003 

Nora D. Volkow, M.D. 

Director

National Institute on Drug Abuse 

6001 Executive Boulevard 

Bethesda, MD 20892 

Dear Dr. Volkow: 

I am pleased to transmit the draft report and recommendations of the Clinical Trials 

Network (CTN) Work Group that was created at your request by the National Advisory Council 

on Drug Abuse at its meeting on May 21, 2003. The report and recommendations reflect the 

unanimous view of the Work Group members. We take full responsibility for the contents. We

remain available to meet with you and/or members of your staff to discuss our conclusions and 

recommendations, though we hope the report makes our views and thinking clear on its own. 

The Work Group is enormously impressed with the hard work and solid achievements of 

the NIDA CTN staff and the hundreds of professionals involved throughout the Network. We

think you and everyone at NIDA should be proud of the CTN and hopeful about the enormous 

potential it holds to improve drug treatment. 

To be sure, we heard about the growing pains of the CTN, but remembered that no one 

learns to walk without falling. We were impressed that the CTN operating structures have taken 

time and energy to learn from their early experiences and have made adjustments as they move 

the CTN forward. The Work Group has also focused on the future, as well as the opportunities 

that exist to strengthen and expand the foundation that has been built. We have also placed 

emphasis on improving the levels of collaboration throughout NIDA, other Institutes, and the 

CTN. 

The members of the Work Group and I would like to thank Denise Pintello, Ph.D., 

M.S.W., and Sarah Michaud for their support throughout the process. They helped mightily by 

monitoring the Work Group’s progress and played major roles in editing the draft report. Thank 

you for this opportunity to support NIDA’s mission. 

Major funding

is provided by

a grant from the

Robert Wood

Johnson Foundation

to the Boston

University School

of Public Health.

Sincerely, 

David L. Rosenbloom, Ph.D. 

Chairman 

Clinical Trials Network Work Group 
National Institute on Drug Abuse 

National Institutes of Health 

REPORT AND RECOMMENDATIONS OF THE 

CLINICAL TRIALS NETWORK 

WORK GROUP 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS i
TABLE OF CONTENTS

I. PREFACE................................................................................................................................................ 2

II. EXECUTIVE SUMMARY.................................................................................................................... 3 

III. THE NIDA CLINICAL TRIALS NETWORK................................................................................... 7 

IV. FINDINGS IN RESPONSE TO THE CHARGE FROM THE DIRECTOR

 OF NIDA ................................................................................................................................................. 9

V. FUTURE DIRECTIONS: RECOMMENDATIONS FROM THE CTN 

 WORK GROUP.................................................................................................................................... 12

Core Recommendation ............................................................................................................................ 12 

Recommendations Relating to the Placement of the CTN Within NIDA 

and Integration With Other NIDA Structures, and Its Relationship to NIAAA and NIMH.................... 14 

Recommendations Relating to the Appropriate Size of the CTN............................................................ 15 

Recommendations Relating to Areas of Appropriate Research for the 

CTN and Standards for Conducting Research Within the CTN .............................................................. 15 

Recommendations Relating to CTN Operations and Budgets................................................................. 18 

Recommendations Relating to Dissemination and Diffusion of CTN Materials, Results, Training

Modules, and Other Ways to Improve

the Quality of Treatment and Prevention................................................................................................. 19 

VI. REFERENCES..................................................................................................................................... 22

VII. APPENDICES..................................................................................................................................... 23

APPENDIX A: CTN NODES ....................................................................................................................... 24 

APPENDIX B: GENERAL CTN STRUCTURE DEFINITIONS .......................................................................... 26 

APPENDIX C: CTN PROTOCOL PORTFOLIO .............................................................................................. 27 

APPENDIX D: CTN BUDGET EXPENDITURES............................................................................................ 30 

APPENDIX E: CLINICAL TRIALS NETWORK WORK GROUP ....................................................................... 31 

APPENDIX F: CTN WORK GROUP MEETING AGENDA FOR AUGUST ........................................................ 32 

APPENDIX G: CTN WORK GROUP MEETING AGENDA FOR OCTOBER...................................................... 34

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 1 
Clinical Trials Network Work Group 

Draft Report and Recommendations 

I. PREFACE 

The members of the Clinical Trials Network (CTN) Work Group would like to acknowledge the admirable 

work of the National Institute on Drug Abuse and CTN staff as well as the CTN Node participants for their 

creativity and diligence in fulfilling the goals of the Network since its inception nearly 5 years ago. Since 

1999, the CTN has gone through a steep learning curve, inventing new procedures, often through long and

complex committee work. The CTN Work Group hopes that its efforts in compiling the following

recommendations and the continuing growth of the CTN will lead to an even more productive Network in

which the talents of the academic and community partners are focused on improving treatment and 

prevention of substance use disorders in their communities without undue administrative burden. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 2 
II. EXECUTIVE SUMMARY 

The National Institute on Drug Abuse (NIDA), an Institute within the National Institutes of Health (NIH), 

provides national and international leadership for research on drug abuse and addiction. Over the past three

decades, findings from NIDA’s research efforts have produced advances in understanding drug abuse and 

addiction, which has led to the development of new treatment and prevention approaches. Despite the

development of science-based advances, only some of the research findings were reaching patients in the 

community-based settings where most drug abuse treatment is provided. 

In 1998, the Institute of Medicine (IOM)/National Academy of Sciences published a report titled Bridging

the Gap Between Practice and Research: Forging Partnerships With Community-Based Drug and Alcohol

Treatment (Lamb et al., 1998). The IOM report recommended the creation of a research infrastructure to 

test the effectiveness and usefulness of new and improved treatments in real-life settings with diverse 

populations. NIDA established the Clinical Trials Network (CTN) in 1999 to enhance the delivery of

scientifically based treatments to drug-abusing patients in community-based settings. The CTN now has 17

Nodes (research centers) and 116 participating Community Treatment Programs (CTPs). (See map in

Appendix A.) 

The CTN Work Group, created by the NIDA Director, Nora D. Volkow, M.D., in 2003, comprised 

members from the National Advisory Council on Drug Abuse and distinguished leaders from the drug

abuse and addiction field. The purpose of the CTN Work Group was to review the CTN program and

advise NIDA on its future development. The NIDA Director charged the CTN Work Group to address the 

mission, scope and vision, achievement of goals, and operational efficiency of the CTN. The Work Group 

was asked to assess the role of the CTN in prevention, treatment, training, HIV/hepatitis C research, 

involvement with the medical community, and collaboration with other Institutes. 

This final report from the Work Group includes a background review of the CTN portfolio since its

inception, recommendations to fortify the current CTN research mission, examination of the organization 

and management of CTN and its interactions with other NIDA Divisions and Centers, and the potential of

the CTN as a platform for other research and training efforts. The Work Group makes one core 

recommendation as well as recommendations in six areas of concern. 

CORE RECOMMENDATION 

The CTN Work Group recommends that the Network be continued and that it become a central strategic 

element in the future plans of NIDA, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), 

and the National Institute of Mental Health (NIMH) to diffuse research to improve the quality of treatment

for substance use disorders in communities throughout the country. 

OUR UNDERSTANDING OF THE MISSION OF THE CTN IN THE FUTURE 

The Work Group believes that the unique mission of the CTN differentiates the Network from other NIDA

and NIH clinical research efforts. The primary mission is: 

• To study the impact of evidence-based practices when they are broadly disseminated in diverse 

settings and populations; and 

• To study the impact of evidence-based practices modified to be more readily adoptable. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 3 
The secondary mission of the CTN is: 

• To serve as a platform for a broad variety of basic and applied research―both inside NIDA and 

perhaps outside the Institute―that is not yet ready for dissemination; 

• To provide state-of-the-art examples of drug abuse treatment and prevention; 

• To expose researchers, practitioners, and agencies to the benefits of mutual collaboration;

• To help inform NIDA about practical issues in need of research; 

• To study how to disseminate evidence-based practices successfully; and 

• To support the dissemination of scientific results to the practice community. 

RECOMMENDATIONS RELATING TO THE PLACEMENT OF THE CTN WITHIN NIDA AND 

INTEGRATION WITH OTHER NIDA STRUCTURES, AND ITS RELATIONSHIP TO NIAAA 

AND NIMH

• The CTN should remain housed in NIDA’s Office of the Director for the foreseeable future, with a

senior officer, perhaps the Deputy Director, designated with clear final decisionmaking authority. 

To facilitate collaboration throughout NIDA, a coordinating structure should be created under the 

designated official to include the Center for Clinical Trials Network (CCTN) Director, NIDA

Division Directors, and other senior officers whose work can impact or be impacted by the CTN.

• The Director of NIDA should create a formal mechanism for input and collaboration on CTN policy

and operations from NIAAA and NIMH, with a goal of developing joint research and training 

projects using the diverse populations in the CTN.

RECOMMENDATIONS RELATING TO THE APPROPRIATE SIZE OF THE CTN 

• As the re-funding cycle is addressed, the size of the CTN should be rationalized to ensure

adequate access to the broad spectrum of Americans with substance use disorders in all regions of 

the country. 

• There should be sufficient Nodes to plan a growing portfolio of research, training, and dissemination 

projects. At least some funding should be flexible enough to enable a Node to sponsor innovative 

work in collaboration with its CTPs that may lead to larger practical clinical trials. 

• NIDA should announce a single competition covering the first two rounds of initial funding (11

Nodes). The announcement should clearly state the criteria for selection. 

RECOMMENDATIONS RELATING TO AREAS OF APPROPRIATE RESEARCH FOR THE 

CTN AND STANDARDS FOR CONDUCTING RESEARCH WITHIN THE CTN

• The CTN should deliver its primary mission through practical clinical trials (PCTs) of

interventions that have been shown to be effective through prior empirical research. 

• Efficacy research that examines the impact of existing interventions that are modified so as to 

make them simpler, more clinically friendly, more cost-effective, or otherwise more useful in

diverse practical settings may also be conducted in the CTN at appropriate scale. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 4 
• Research on how to disseminate empirically supported research at the appropriate scale and in 

support of the PCTs being investigated should be performed in the CTN as a means of supporting

its primary mission. 

• The Work Group believes that a wide variety of research is needed to examine how to disseminate

empirically supported treatments successfully in diverse practical settings. Studies of this kind 

may involve the evaluation of innovative methods―such as new methods of training practitioners 

in empirically supported interventions and new means of modifying organizations to make them

more receptive to adoption of empirically supported methods―that have relatively limited

empirical support. However, because the level of analysis of such research is inherently larger

(e.g., involving larger numbers of clinicians or agencies) and because methods of this kind are

necessarily involved in mounting the more primary research purposes of the CTN, such studies

logically belong within the funding and evaluation streams of the CTN. 

• CTN trials can and should provide new information about the possible differential impact of

interventions on various population groups by taking care to design these questions into the 

studies and recruiting participation from the heterogeneous populations within the entire range of 

participating CTPs. 

• CTN dissemination-oriented research should include cost-benefit or cost-effectiveness analyses to 

assist treatment programs and funders in making decisions about implementing interventions. 

• The Work Group recognizes that these kinds of analyses often raise complex measurement issues, 

especially in assigning costs to activities within existing entities and providing fully quantified

measures of benefit. Nevertheless, the question of how much it will cost to implement a new 

treatment protocol and whether the result will be better than the benefits the program now gets is 

at the heart of many barriers to widespread dissemination of new approaches. 

• Over time, the special characteristics of the CTN should enable it to emerge as an active 

participant in a wide variety of substance use disorder research. For example, the CTN has access 

to a huge and heterogeneous pool of genetic material—including families—that could speed

collection and analysis of genetic markers. CTPs in the Network may be in a better position than 

traditional NIDA researchers to maintain long-term contact with patients and families for followup 

and longitudinal studies. 

• The CTN can now be used as a vehicle for Phase III trials of drugs that will be submitted to the 

Food and Drug Administration (FDA) for NIDA approval. Phase III medication studies could be 

carried out in collaboration with other NIDA Divisions to provide them with access to the diverse 

populations served in the CTN. Data quality and monitoring standards for CTN protocols should

be appropriate to the risks actually involved. 

• The good clinical practice (GCP) model for randomized clinical trials being submitted to the FDA 

is not the only optimal model for selection for all protocols. 

RECOMMENDATIONS RELATING TO CTN OPERATIONS AND BUDGETS 

• To fulfill its mission, the CTN, over time, should become open to receiving and reviewing 

proposals to use the Network as a platform for research emanating from outside the CTN. In 

many cases, funding for such proposals will also come from outside the CTN; but in other areas 

that closely align with the primary mission of the CTN, consideration should be given to funding

them from the CTN budget. 

• The process for developing, reviewing, approving, and funding research protocols should be 

further simplified and made more transparent. The need for an external Protocol Review Board 

and an external Data Safety Monitoring Board (DSMB) should be carefully reexamined in light of 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 5 
the CTN’s actual experience. If NIDA determines that such external review will remain

necessary, it should be integrated early in the process (as apparently happens in the U.S.

Department of Veterans Affairs system), and actions should be transparent to the CTN to avoid 

wasted effort. 

• Budgets should be developed and attached to protocols early in the review process and should

cover the expected cost for the life of the protocol as long as progress is being made on the 

research plan. Currently, protocols are being approved for multiyear periods, but funded on a 

year-to-year basis. An appropriate accountability and monitoring system should be established to 

force corrective action or cancellation if progress on a particular protocol or in a particular study

site is not being made. 

• A single or limited number of Coordinating Centers should be established to manage all stages of 

protocol training, implementation, and data monitoring. An independent Coordinating Center 

should be selected through a competitive bidding process in close coordination with the CTN 

Steering Committee, and it should endorse the plans under the terms and conditions of the 

cooperative agreement. 

RECOMMENDATIONS RELATING TO DISSEMINATION AND DIFFUSION OF CTN 

MATERIALS, RESULTS, TRAINING MODULES, AND OTHER WAYS TO IMPROVE THE 

QUALITY OF TREATMENT AND PREVENTION 

• To fulfill the CTN’s mission, planning and resources for dissemination should be included in all 

protocol development and review, not left as a matter to be addressed after the fact. Principal

Investigators and their CTP colleagues should identify and address likely barriers to widespread

adoption during the planning phase of a study, and they should test approaches to overcoming

such barriers in the practical clinical trials supported in the CTN. NIDA should consider

providing additional resources within its own operations and the CTN to promote broader 

dissemination of evidence-based treatments. 

• NIDA and other Institutes should consider new research initiatives that address barriers to

dissemination of effective treatment interventions. 

• The CTN should work closely with NIDA and other agencies working on dissemination,

especially the Addiction Technology Transfer Centers (ATTCs) network, operated by the 

Substance Abuse and Mental Health Services Administration (SAMHSA). 

• NIDA and the CTN should establish a continuing collaboration with directors of State treatment 

and prevention agencies, perhaps through the auspices of the National Association of State 

Alcohol and Drug Abuse Directors (NASADAD), to foster dialogue about the CTN and NIDA

research agenda and to enhance the probability of broad dissemination of effective treatment

regimens. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 6 
III. THE NIDA CLINICAL TRIALS NETWORK 

INTRODUCTION 

The National Institute on Drug Abuse (NIDA), an Institute within the National Institutes of Health (NIH), 

provides national and international leadership for research on drug abuse and addiction. NIDA supports a 

comprehensive research portfolio that focuses on the biological, social, behavioral, and neuroscientific

basis of drug abuse as well as its causes, prevention, and treatment. Over the past three decades, findings 

from NIDA’s research efforts have produced dramatic advances in understanding drug abuse and addiction 

and have led to the development of new treatments and therapies to help individuals with drug abuse and

addiction. Despite the development of these science-based advances, only some of the advances were 

reaching patients in the community-based settings where most drug abuse treatment is provided. 

In 1998, the Institute of Medicine (IOM) and the National Academy of Sciences published a report titled

Bridging the Gap Between Practice and Research: Forging Partnerships with Community-Based Drug

and Alcohol Treatment (Lamb et al., 1998). The IOM report recommended the creation of an entity to

facilitate two needs: (1) the creation of a research infrastructure to test the effectiveness and usefulness of

new and improved treatments in real-life settings with diverse populations; and (2) the creation of a 

mechanism for the systematic study of processes and factors involved in the incorporation of new and 

improved interventions into community-based drug treatment. 

Based on the IOM report, NIDA established the Clinical Trials Network (CTN) in 1999 to enhance the 

delivery of scientifically based treatments to drug-abusing patients in community-based settings. NIDA 

developed a pilot program based on the National Cancer Institute (NCI) model within NIH. The initial 

focus of the CTN was on integrating medication and behavioral therapies and translating these efforts to

community treatment programs. 

The CTN structure called for academic centers, or “Nodes,” to link up with Community Treatment 

Programs (CTPs) to undertake research protocols. The CTN was established within the framework of a 

cooperative agreement, allowing NIDA to maintain a key role in the Network’s management and 

administration, including the process by which protocols are implemented. The CTN currently comprises 

17 research Nodes across the country with 116 CTPs across 27 states. Appendix A contains a map of CTN 

Nodes, and Appendix B provides definitions of CTN organizational structures. 

Since its inception, the CTN has reviewed and approved 26 protocols in three rounds of funding. The CTN 

released its first Request For Applications (RFA) on January 11, 1999, which resulted in the funding of

seven protocols. Research began with the first protocol in January 2001. The Network released its second

RFA on December 20, 1999, and accepted five protocols. The intention of the second RFA was to develop 

a geographically diverse and encompassing Network. The third RFA, released on November 20, 2001,

resulted in nine new protocols for the CTN. The intention of the third wave was to expand the geographic

distribution of CTN research, to encompass more subpopulations of racial/ethnic minority groups, and to

broaden the range of treatment providers who work under varying systems of reimbursement and

organization of care. 

Topics covered in the first three rounds of CTN-funded protocols include AIDS/HIV, family therapy and 

treatment, motivational incentives, medication, motivational enhancement and interviewing, services and 

nontreatment, and 12-step programs. Twenty-one protocols are currently in various stages of

implementation. Appendix C provides additional information on CTN protocols, including topic, Node, 

and lead investigator. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 7 
CTN grantees participate in the cooperative agreement between NIDA and the CTN to conduct and

participate in coordinated multisite clinical trials of behavioral, pharmacological, and combined

behavioral/pharmacological therapies for drug abuse and addiction, and to conduct research on practices 

(e.g., studies of factors that affect successful adoption of new treatments). The research is conducted in 

community-based treatment settings in collaboration with other awardees and with NIDA. Each awardee 

functions as a CTN research Node. 

More than 3,500 patients are participating in these studies. Although it is too early to know if these 

protocols will lead to wide adoption of practices and technologies, several of the premises have been

proven: CTPs are interested in participating in rigorous scientific research and are capable of implementing 

rigorous trials. Appendix D presents CTN budget expenditures for fiscal years 1999 through 2003. 

The CTN currently uses the good clinical practice (GCP) model for data integrity for pharmacotherapy and

various behavioral therapy studies—even when the goal does not involve conducting a pivotal study for

FDA submission of a New Drug Application (NDA). Because the treatment community, not the FDA, is 

the audience and participants of the vast majority of CTN studies, it is logical that NIDA might not need to 

behave as if it were a pharmaceutical company going to the FDA for approval. The CTN has employed 

contractors to enforce the GCP model, which has been costly. To the Work Group’s knowledge, no outside 

agency, regulatory body, or review group is imposing these costly standards on NIDA or the CTN. 

The current Center for Clinical Trials Network (CCTN) is led by its Director, Betty Tai, Ph.D., who reports 

directly to NIDA’s Office of the Director. She is supported by approximately 10 staff members and 8 fulltime contractors. Dr. Tai has proposed a new structure for the CTN, which has been informally

implemented. The new structure has four branches: program development, program operations, statistical

services and informatics, and program dissemination. 

THE CTN WORK GROUP 

The CTN Work Group, created by the NIDA Director, Nora D. Volkow, M.D., comprises NIDA Advisory

Council members and leaders from the drug abuse field. Appendix E presents the list of CTN Work Group

members. The purpose of the CTN Work Group is to evaluate the CTN program and advise NIDA on

strategies to maximize the transfer of research into practice, culminating in a final written report that 

includes a background review of the CTN portfolio since its inception, recommendations to fortify the 

current CTN research mission, examination of the organization and management of the CTN and its

interactions with other NIDA Divisions and Centers, and the potential of the CTN as a platform for other 

research and training efforts. 

Over the past 4 months, the CTN Work Group has held two meetings at which representatives from NIDA, 

the National Cancer Institute (NCI), the NIDA CCTN, and other CTN participants have delivered 

presentations and conducted discussions with the Work Group in open and in executive sessions (see 

Appendix F and Appendix G for the meeting agendas). The Work Group reviewed these discussions and 

documents and produced several drafts of the written report. The report was finalized through e-mail 

communication and conference calls. All recommendations in the final report reflect the consensus of the 

Work Group unless specifically noted otherwise. 

CHARGE FROM THE DIRECTOR OF NIDA TO THE CTN WORK GROUP 

The NIDA Director asked the CTN Work Group to specifically address the following ten questions: 

1. What has been the mission of the CTN?

2. Is the mission adequate in specificity, scope, and vision?

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 8 
3. How well has the CTN achieved its goals?

4. How efficiently has the CTN operated?

5. Where should the CTN be in 5 years?

6. Can the CTN play a role in prevention as well as treatment?

7. What is the role of the CTN in HIV/hepatitis C research?

8. What is the role of the CTN in training?

9. What is the role of the CTN in involving the medical community?

10. What is the role of the CTN in collaboration with other Institutes?

IV. FINDINGS IN RESPONSE TO THE CHARGE FROM THE 

DIRECTOR OF NIDA 

The CTN Work Group’s general conclusions are organized as responses to the Director’s questions. These 

conclusions led to the detailed recommendations presented in the later sections. 

1. What has been the mission of the CTN?

• The original mission was unidirectional, from NIDA to the communities. There was hope that 

research would provide a steady flow of new medications that could be tested in diverse

community settings. However, the community treatment programs (CTPs) recruited to the CTN 

quickly expected that the flow of information and decisionmaking should be bidirectional. 

• The mission statement of the CTN had two components: “(a) to conduct multisite clinical trials to

determine the effectiveness of drug abuse treatment interventions in diverse community-based

treatment settings and diverse patient populations, and (b) to transfer research results to treatment

programs, clinicians, and their patients to improve the quality of drug abuse treatment throughout 

the Nation.” 

• The CTN was established and expanded rapidly with broad statements of research goals and areas, 

but few details. The Principal Investigators, Node directors, and a small number of NIDA CTN 

staff had to develop all the operating and rule-setting systems quickly to give life to the mission, 

too often in isolation from other NIDA Divisions. The Work Group was impressed with the 

results achieved. 

2. Is the mission adequate in specificity, scope, and vision? 

• The bidirectional communication and genuine partnership with CTPs evolved quickly and gave 

strength to the CTN with a broader mission. The establishment of a partnership between

researchers and practitioners is essential to providing new treatments to address the critical needs 

and to provide suitable treatments for communities served by CTPs. 

• CTN members invested an enormous amount of energy in developing and redeveloping processes 

to get the Network up and running. As stated, the current mission is too narrow methodologically

and too broad conceptually to incorporate all of the CTN’s goals and expectations. The mission 

provided no necessary link to previous research, nor did it differentiate aspects of the CTN

mission that warrant multisite trials from those that do not. The mission provided little effective 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 9 
guidance to the CTN and little reason for other NIDA Divisions to feel connected to the effort. 

The roadmap developed by the CTN was a step forward, but the Work Group felt that it would be 

helpful to make recommendations about questions asked by the NIDA Director if the group first

spent time trying to state more explicitly the core mission of the CTN. 

• The Work Group has listed specific recommendations in this report that will help refine the scope 

and vision of the CTN to go forward to achieve its original mission. 

3. How well has the CTN achieved its goals? 

• Although it is too early to know if CTN protocols will be disseminated widely, one of the key 

early questions about the CTN has been answered. It is clearly possible to engage CTPs in real 

research and to conduct rigorous trials in community treatment settings. 

• It is clearly possible to establish strong working relationships with multilateral learning among the 

CTN, academic research sites, and community programs in the drug abuse area. 

• Researchers report they are learning important lessons that improve the quality of their work. 

• CTPs report that their staff members who are participating in particular protocols are being trained 

and learning new skills, which would not have been possible if the Network had not given CTPs a 

voice in developing new research to improve care. 

• There is little evidence so far of dissemination beyond the actual participants. As the first CTN 

research protocol results have not yet been published, it is still too early in the process to evaluate

dissemination efforts accurately. 

• Although initial steps have been taken to initiate the plan for dissemination and training, it is now 

time to devote more resources to carry out these plans. The Work Group takes note of the work of

the Dissemination Committees, especially in compiling a bibliography of past dissemination

research. Specific recommendations concerning dissemination and training are made in Section V. 

4. How efficiently has the CTN operated?

• Participants have experienced a steep learning curve, especially through three rounds of expansion

in 4 years. The startup of the CTN was not necessarily conducted in the most efficient way 

possible. Lessons have been learned in the past 4 years, and the CTN has developed and 

implemented much more efficient review and planning processes. 

• It is quite possible that the wheel has been reinvented several times within the CTN because of

inadequate collaboration within NIDA. However, the Work Group feels the focus of the CTN 

should not be on this, but on the future instead. 

• One result of the speed and complexity of the startup has been heavy reliance on outside 

contractors. The Work Group concluded that reliance on contractors should be carefully reviewed

and audited to draw lessons for the future. The Work Group believes that if its recommendations

are adopted, there will be less need for contractors in the future. In any event, the Work Group

believes that all contracts should be competitively bid with clear deliverables and accountability to

ensure that investigators and the CTN protocol development process retain substantive control. 

• The CTN evaluation process needs to include adequate assessments of cost, time, and personnel to 

allow estimation of the cost of development and implementation as well as the probable 

community effectiveness of new therapies. Now that the CTN has established evaluation

mechanisms for process measures (e.g., number of protocols approved, number of databases 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 10 
locked), it is time to develop a mechanism to measure the dissemination and effectiveness of its 

efforts. 

• The Work Group believes that its recommendations will improve the efficiency of the CTN and 

enable Principal Investigators, CTPs, and key NIDA staff to focus on important issues related to

the mission. 

5. Where should the CTN be in 5 years?

• The CTN should be at the core of NIDA, the National Institute on Alcohol Abuse and Alcoholism

(NIAAA), and the National Institute of Mental Health (NIMH) as a vehicle for translating research

into practice and improving treatment processes and outcomes. The Network should be

participating in key NIDA initiatives (e.g., genetic pooling) and providing important input to the 

entire research agendas of NIDA, NIAAA, and NIMH. 

• The NIH Director Elias A. Zerhouni, M.D., recently established the NIH Roadmap Initiative for 

Medical Research. The NIH Roadmap is designed to accelerate medical research by identifying 

new research pathways, building research teams of the future, and re-engineering the clinical 

research enterprise. Within the NIH Roadmap framework, primary objectives include the 

integration of clinical research networks and the development of regional translational research

centers. NIDA, in partnership with other NIH Institutes, should explore avenues for the CTN to 

participate and contribute to the Roadmap Initiative. The Work Group believes that the current

CTN roadmap is a good start toward that contribution and recommends its further refinement. 

6. Can the CTN play a role in prevention as well as treatment?

• The CTN could play a role in prevention dissemination research, but it is not well equipped to do

so now. The Network currently plays a role where an overlap exists between treatment and 

prevention—for example, in family therapy studies and relapse prevention—but primary

prevention has not been a focus of activity. 

• Some CTPs have prevention programs, and a few current researchers have experience conducting 

prevention research; however, many do not.

• There is little connection between the CTN, school systems, community agencies doing

prevention work, and other locations where research might need to be carried out. New network

development would be needed to build a strong research platform for prevention issues. 

7. What is the role of the CTN in HIV/hepatitis C research?

• Research in any specific area is now largely dependent on the interests of investigators in 

individual Nodes. Investigators should present the CTN with ideas for their particular areas of 

interest. 

• The CTN also has established special interest groups of researchers and CTP partners to discuss

and propose new areas for research. For example, three protocols have emerged from an HIV 

interest group.

• The Work Group found that the current “closed” nature of the CTN protocol development process

is a potential weakness for future research areas. The Group was particularly concerned that there 

be a way for research ideas to flow to the CTN from all areas of NIDA. Specific 

recommendations are made to address this in Section V, Future Directions: Recommendations 

From the CTN Work Group. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 11 
8. What is the role of the CTN in training?

• During its meetings, the Work Group heard instances of very intense and high-quality training

being provided in the context of implementing specific protocols from CTP members. 

• The Work Group also has heard anecdotal evidence that staff members participating in trials are 

improving overall skills and are being retained in their organizations. 

• The Work Group was unable to identify any resources dedicated to an overall training mission 

within the Nodes. If NIDA determines that it would be useful for the CTN to train new 

researchers in the Nodes or community providers in the Network, the Work Group believes 

additional funds will need to be targeted to these purposes. 

• The Work Group also found no evidence of the impact on training beyond the participating 

centers, although some evidence suggested that contact with State agencies might lead to 

improvements in issues such as payment for supervision. This could have an important long-range 

impact on better training and outcomes. 

9. What is the role of the CTN in involving the medical community?

• Most CTPs have minimal medical involvement. Therefore, the CTN is not currently a vehicle for 

involving the broader medical community in drug treatment. 

10. What is the role of the CTN in collaboration with other Institutes?

• The Work Group noted a separation between the CTN and other NIDA Divisions in the effective 

use of the Network as a research platform. 

• The Work Group learned that NIAAA representatives are starting to attend some meetings, but 

noted that, to date, there have been no examples of cross-Institute collaboration in the CTN. 

Recommendations that address this issue are included in Section V, Future Directions: 

Recommendations From the CTN Work Group. 

V. FUTURE DIRECTIONS: RECOMMENDATIONS FROM THE 

CTN WORK GROUP 

Please note that the recommendations made by the CTN Work Group are in italics. 

CORE RECOMMENDATION 

The CTN Work Group recommends that the Network be continued and that it become a 

central strategic element in the future plans of NIDA, NIAAA, and NIMH to diffuse 

research that improves the quality of treatment for substance use disorders in

communities throughout the country. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 12 
OUR UNDERSTANDING OF THE MISSION OF THE CTN IN THE FUTURE 

The Work Group believes that the unique mission of the CTN differentiates the Network from other NIDA

and NIH clinical research efforts. Clarifying this mission will provide a strong basis for better 

collaboration with other NIDA and NIH programs in the future. 

The Work Group believes that the primary mission of the CTN is to help bridge the gap between science 

and practice, so as to treat and prevent substance use disorders more successfully. The Network 

accomplishes this mission primarily by conducting practical clinical trials and other forms of effectiveness 

research regarding empirically based, clinically relevant intervention and prevention programs. These 

programs will be for diverse populations recruited from heterogeneous settings, as assessed against a range

of substance use disorders, mental health, physical health, social, cost, and organizational outcomes. CTN 

research can also help determine the processes through which these interventions produce their effects. 

The Network also conducts research on how to modify existing empirically based interventions to make 

them more acceptable or practical with diverse populations and within heterogeneous practice settings, 

without unduly modifying their efficacy. In addition, the CTN conducts research on the training, 

professional, organizational, policy, or financial means necessary for successfully disseminating effective 

clinical treatments into diverse practical settings. Finally, the Network works with State, Federal, and other 

interested agencies and parties to transfer research results to treatment and prevention programs, providers, 

and consumers so as to improve the quality of drug abuse treatment and prevention.

The primary mission can be summarized as follows: 

• To study the impact of evidence-based practices when they are broadly disseminated in diverse 

settings and populations; and 

• To study the impact of evidence-based practices modified to be more readily adoptable. 

The Work Group also believes that the CTN has a secondary mission, afforded by the processes and 

outcomes necessarily produced in service of its primary mission. The secondary mission of the CTN is

outlined in the text below. 

• A network of the kind needed to conduct practical clinical trials can provide a valuable platform

for a vast variety of other kinds of research. Much of this research may be more central to the 

mission of other NIDA Divisions or other NIH Institutes, particularly NIMH and NIAAA. For 

example, a well-functioning CTN might enable the collection of important genetic databases. 

Research opportunities of this kind provide reasons to be hopeful about the positive impact of the 

Network on NIDA in general; however, other NIDA Divisions and NIH Institutes should not be

confused with the primary mission of the CTN, and they should not necessarily be linked to the 

CTN’s separate funding structure. 

• The CTN also provides good examples of high-quality treatment in actual practical settings and

develops a cadre of researchers, practitioners, and agencies that have been exposed directly to the 

benefits of collaboration. In the long run, these treatments could have a large impact on NIDA

research and its dissemination efforts, and they can have a very positive impact on the practice 

base. These benefits are a side effect of the processes inherent in the CTN, however. If these 

goals were the primary mission, less costly methods of their achievement would probably be 

available. 

• The active involvement of the CTPs helps NIDA identify crucial practical research questions 

that―although not yet ready for dissemination and effectiveness research and thus not yet ready 

for CTN testing―may nevertheless benefit from special forms of NIDA funding outside of the 

normal CTN funding. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 13 
• The Work Group noted that the CTN engenders a dynamic tension between research knowledge

and practical needs that is both uncomfortable for some parts of NIDA and drug abuse treatment 

and helpful in the long run to the health of the Institute and to drug abuse treatment if the CTN is 

perceived correctly. 

In summary, the secondary mission of the CTN is: 

• To serve as a platform for a broad variety of basic and applied research―both inside and perhaps 

outside the Institute―that is not yet ready for dissemination; 

• To provide state-of-the-art examples of drug abuse treatment and prevention; 

• To expose researchers, practitioners, and agencies to the benefits of mutual collaboration;

• To help inform NIDA about practical issues in need of research; 

• To study how to disseminate evidence-based practices successfully; and 

• To support the dissemination of scientific results to the practice community. 

RECOMMENDATIONS RELATING TO THE PLACEMENT OF THE CTN WITHIN NIDA AND 

INTEGRATION WITH OTHER NIDA STRUCTURES, AND ITS RELATIONSHIP TO NIAAA 

AND NIMH 

The CTN should remain housed in NIDA’s Office of the Director for the foreseeable 

future, with a senior officer, perhaps the Deputy Director, designated with clear final

decisionmaking authority. To facilitate collaboration throughout NIDA, a coordinating 

structure should be created under the designated official to include the CCTN Director, 

NIDA Division Directors, and other senior officers whose work can impact or be

impacted by the CTN. 

The Work Group discussed a wide range of possible alternatives for locating the CCTN function. Members 

recognized the strains on the CCTN Director’s time and heard logical reasons why the CTN could be 

located within several existing NIDA Divisions. However, the Work Group noted the potential for 

additional strains and impediments to effective Institute and external collaboration in any of the 

alternatives. Therefore, members recommend that the CTN stay where it is in the Office of the Director. 

The Work Group believes that the issues of internal and external coordination need more attention than

they can get without new mechanisms at the Director’s level and clear authority to set priorities and resolve 

disputes. These kinds of issues may become more acute in a period of slower budget growth and with a

maturation of the CTN’s ability to identify and conduct important dissemination research. The Work

Group also believes such a coordinating mechanism will provide all NIDA Divisions with a place to 

engage in long-term strategic planning of a research agenda that clearly focuses on practical dissemination. 

A coordination structure that involves other Divisions may have longer-term intellectual benefits as well, 

such as bringing new findings into the CTN as well as developing and refining administrative vehicles for

the use of the CTN as a platform. 

The Director of NIDA should create a formal mechanism for input and collaboration on

CTN policy and operations from NIAAA and NIMH, with a goal of developing joint 

research and training projects using the diverse populations in the CTN.

Very large numbers of patients in CTP settings have co-occurring disorders associated with drugs, alcohol,

and mental illness. As collaboration in research and administration among the Institutes increases, the 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 14 
Network provides an excellent vehicle to reach these populations with interventions shown to meet their 

multiple needs. 

RECOMMENDATIONS RELATING TO THE APPROPRIATE SIZE OF THE CTN 

As the re-funding cycle is addressed, the size of the CTN should be rationalized to ensure

adequate access to the broad spectrum of Americans with substance use disorders in all 

regions of the country. 

There should be sufficient Nodes to plan a growing portfolio of research, training, and

dissemination projects. At least some funding should be flexible enough to enable a Node

to sponsor innovative work in collaboration with its CTP partners that may lead to larger 

practical clinical trials. 

NIDA should announce a single competition covering the first two rounds of initial 

funding (11 Nodes). The announcement should clearly state the criteria for selection.

RECOMMENDATIONS RELATING TO AREAS OF APPROPRIATE RESEARCH FOR THE 

CTN AND STANDARDS FOR CONDUCTING RESEARCH WITHIN THE CTN

The CTN should deliver its primary mission through practical clinical trials (PCTs) of

interventions that have been shown to be effective through prior empirical research. 

The original CTN mission statement spoke only of multisite trials and did not specifically mention

empirically supported interventions. The Work Group believes that this should be corrected. The primary 

mission will indeed require multisite randomized controlled trials, but these should be focused on PCTs 

with empirically supported interventions (Tunis et al., 2003). By their very nature, PCTs involve 

comparative evaluations of interventions used with diverse populations and in diverse practical settings. 

Insofar as possible, these trials should be designed to answer questions about whether the proposed

intervention is better than currently used interventions. Although PCTs are randomized controlled trials, 

implementing a program of PCTs also requires other research methods or designs. For example, PCTs may

need to compare an empirically supported treatment not to another well-defined treatment, but to treatment

as usual. 

Very difficult empirical issues must be faced in documenting and measuring treatment as usual—issues that

the CTN is well suited to help solve for the entire field. The research methods needed in this area are not 

randomized controlled trials. Similarly, by definition, PCTs focus on broader and longer-term health

outcomes. In some cases, these outcomes might be characterized using methods other than randomized

controlled trials. For example, simple descriptive studies might examine the course of health outcomes 

produced by empirically supported treatments over a long-term followup. The Work Group’s point is that, 

although PCTs should form the core of the CTN portfolio, accomplishing its primary mission may also 

require assessment development, evaluation research, services research, cost-benefit analyses, 

organizational research, and so on―some of which may properly belong within the CTN funding and

project approval stream, despite the fact that these studies are not multisite randomized controlled trials. 

Efficacy research that examines the impact of existing interventions that are modified so 

as to make them simpler, more clinically friendly, more cost-effective, or otherwise more

useful in diverse practical settings may also be conducted in the CTN at appropriate 

scale. 

Early efficacy research should normally be conducted on a small scale, not at multiple sites. Although 

most of this kind of research will be conducted outside the CTN, it makes sense for some of it to occur 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 15 
within the Network. However, the precise compromises that might need to be tested to comport with

practical needs require a healthy negotiation between equal partners, such as that afforded between the

investigators and CTPs within the CTN. Ideally, modifications will be tested against existing methods 

delivered in a fashion that has known efficacy before being deployed in multisite trials, although other 

methods (e.g., examination of within-group effect sizes) may provide an adequate empirical basis for such 

deployment. 

Research on how to disseminate empirically supported research at the appropriate scale 

and in support of the PCTs being investigated should be performed in the CTN as a 

means of supporting its primary mission. 

The Work Group believes that a wide variety of research is needed to examine how to 

disseminate empirically supported treatments successfully in diverse practical settings. 

Studies of this kind may involve the evaluation of innovative methods―such as new

methods of training practitioners in empirically supported interventions and new means 

of modifying organizations to make them more receptive to adoption of empirically 

supported methods―that have relatively limited empirical support. However, because 

the level of analysis of such research is inherently larger (e.g., involving larger numbers

of clinicians or agencies) and because methods of this kind are necessarily involved in

mounting the more primary research purposes of the CTN, such studies logically belong

within the funding and evaluation streams of the CTN. 

CTN trials can and should provide new information about the possible differential impact 

of interventions on various population groups by taking care to design these questions

into the studies and recruiting participation from the heterogeneous populations within

the entire range of participating CTPs. 

The Work Group noted that the NIDA Diversity Plan makes specific reference to the CTN as an important 

element in its strategy to ensure that research is relevant to all-important subgroups in the population. The 

Work Group believes that this objective can be achieved and that important, clinically relevant information

learned by explicitly planning trials to include minority populations that may have been underrepresented

in the original efficacy trials. The value of doing research in diverse settings is diminished if issues of 

diversity are not addressed in the research design.

CTN dissemination-oriented research should include cost-benefit or cost-effectiveness 

analyses to assist treatment programs and funders in making decisions about 

implementing interventions. 

The Work Group recognizes that these kinds of analyses often raise complex 

measurement issues, especially in assigning costs to activities within existing entities and

providing fully quantified measures of benefit. Nevertheless, the question of how much it 

will cost to implement a new treatment protocol and whether the result will be better than

the benefits the program now gets is at the heart of many barriers to widespread

dissemination of new approaches. 

Over time, the special characteristics of the CTN should enable it to emerge as an active 

participant in a wide variety of substance use disorder research. For example, the CTN

has access to a huge and heterogeneous pool of genetic material—including families—

that could speed collection and analysis of genetic markers. CTPs in the Network may be

in a better position than traditional NIDA researchers to maintain long-term contact with

patients and families for followup and longitudinal studies. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 16 
The CTN can now be used as a vehicle for Phase III trials of drugs that will be submitted

to the FDA for NIDA approval. Phase III medication studies could be carried out in 

collaboration with other NIDA Divisions to provide them with access to the diverse 

populations served in the CTN. Data quality and monitoring standards for CTN 

protocols should be appropriate to the risks actually involved. 

The good clinical practice model (GCP) model for randomized clinical trials being

submitted to the FDA is not the only optimal model for selection for all protocols. 

The issues of using the GCP model for data integrity appear to have come under the most strain when

applied to various behavioral therapy studies, but can be equally questioned for many pharmacotherapy

studies when the goal does not involve conducting a pivotal study for FDA submission of a New Drug

Application (NDA). Because the vast majority of CTN studies have the treatment community, rather than

the FDA, as their audience and participants, it is logical that NIDA might not need to behave as if it were a 

pharmaceutical company going to the FDA for approval. 

This flexibility to move outside of the box of highly regulated NDA studies is perhaps a fundamental 

distinction between the trials networks of NIDA and NCI. The NCI network has allowed new medications

for very rare diseases to be brought to market when multiple community sites are required to get a 

sufficient number of patients for a Phase III FDA submission of an NDA. This mission of NDA

submissions is probably not a realistic part of the CTN at this stage of its development because few, if any, 

medications in the substance abuse disorders field merit this type of GCP monitoring and associated cost,

and behavioral interventions neither require nor would benefit from the FDA or other regulatory approval. 

Cost considerations may be an important point in this discussion, but the other consideration involves the 

broader mission of the CTN to move successful new treatments into realistic clinical settings and routine 

clinical practice. Many aspects of GCP procedures and monitoring are not related to goals that are 

embraced by the CTN, including providing good clinical care, using cutting-edge therapies, collecting 

high-quality data, or attaining cost-effective assessments of treatment. Particular GCP procedures that are 

not relevant to these goals cannot be extensively listed here, but include the typical tracking procedures for

protocol deviations, the extensive onsite monitoring of every case report form, and signoffs by investigators 

on many documents and data collection instruments for each subject at every visit. 

The issue of using the GCP model for data integrity is critical in the allocation of limited resources and in

clearly defining the mission of the CTN. The Network is not a contract research organization, and NIDA

has other mechanisms in other Divisions to address such a need, if that need arises for a particular 

treatment. 

Many very high-quality studies have introduced clinical innovations and improved practice without

adopting the detailed procedures of the GCP model that are typically supported by extensive and expensive 

monitoring organizations. In the field of substance use disorders, examples include the NIDA Cocaine 

Collaborative study (Crits-Christoph et al., 1999), Project MATCH (Project MATCH Research Group, 

1998), the acupuncture study (Margolin et al., 2002), and the Marijuana Treatment Project (MTP Research 

Group, in press), all of which were multisite studies. 

Later in this report, the Work Group recommends the establishment of a Coordinating Center to manage the 

many quality assurance tasks that go along with multisite research, but this Coordinating Center must be 

flexible in developing the level of monitoring and data management that is appropriate for the particular 

study. The current structure appears to use an outside contractor to make every study meet current

interpretations of FDA standards for a pivotal study of an NDA submission by a commercial sponsor of a 

new pharmaceutical. The Work Group believes this structure is simply too rigid. The CTN can be in the 

vanguard in developing reasonable and valuable standards for application to clinical research, rather than

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 17 
simply applying the very costly approach of current interpretations of GCP standards. No outside agency, 

regulatory body, or review group is imposing these costly standards on NIDA or the CTN, and no one will 

reward NIDA for imposing this relatively inefficient standard on its work. 

The Work Group believes a more reasonable goal for the CTN will be a major service to the field of 

substance use disorders and to the field of practical day-to-day medicine, where we do need to test effective 

new therapies and determine how to realistically adapt them so that the broader treatment community will 

then adopt them. 

It may be necessary to convene an expert group of clinical investigators to work with the CTN and NIDA

leadership to detail all the minimal standards needed for reasonable studies. This group could provide 

realistic standards for various measures of treatment process and outcome such as the Addiction Severity

Index and the Composite International Diagnostic Interview for psychiatric diagnoses and the time periods

over which outcomes will be measured. This group could also review, in conjunction with the appropriate 

CTN committee’s standard operating procedures, business rules for data acquisition and verification, and 

criteria for considering a priori outcome criteria. The Work Group further believes that much of the work 

involved in meeting this recommendation might be adopted from existing organizations such as the 

Veterans Administration (VA) Cooperative Studies Program or the other NIDA Divisions involved in

clinical research. 

In summary, some new ground is being broken in finding a hybrid model for clinical research that is more

efficient than having each new multisite study redesign its operating procedures. However, the current

iteration of this process needs to become more efficient than the current business of GCP monitoring, 

which was designed for a different purpose than the mission and promise of the CTN. 

RECOMMENDATIONS RELATING TO CTN OPERATIONS AND BUDGETS 

To fulfill its mission, the CTN, over time, should become open to receiving and reviewing 

proposals to use the Network as a platform for research emanating from outside the 

CTN. In many cases, funding for such proposals will also come from outside the CTN, 

but in other areas that closely align with the primary mission of the CTN, consideration

should be given to funding them from the CTN budget. 

This approach to funding and to CTN development cannot ultimately be successful if the Network is 

impermeable. It is the nature of a network, as distinguished from a mere collection of performance sites, 

that projects must be conducted in a fashion that supports cooperation and mutual benefit. Thus, the Work

Group is aware of the complex nature of using the CTN as a platform for basic research or for applied 

research by outside investigators. Nevertheless, the research opportunities the Network affords―and the

perceived mutual benefit between the CTN and other NIDA Divisions, Centers, and Branches―requires

that means be developed to access the Network using funding and project approval streams external to the 

Network and with investigators external to the Network.

It is important that this funding not be channeled entirely through existing Principal Investigators because 

to do otherwise will ultimately lead to a sense that the CTN is a closed shop operated for the benefit of a 

few. Furthermore, the infusion of outside ideas and funding will help ensure the long-term intellectual, 

political, and financial viability of the Network. Balancing these interests will take vision, cooperation, and

communication, particularly by the CCTN leadership. The Work Group recommends that the CTN be 

tasked to develop ways to open the Network, beginning immediately in small ways and increasing over 

time as proper administrative methods are developed.

The process for developing, reviewing, approving, and funding research protocols should 

be further simplified and made more transparent. The need for an external Protocol

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 18 
Review and an external Data Safety Monitoring Board (DSMB) should be carefully

reexamined in light of the CTN’s actual experience. If NIDA determines that such

external review will remain necessary, it should be integrated early in the process (as 

apparently happens in the VA system) and actions should be transparent to the CTN to

avoid wasted effort. 

Budgets should be developed and attached to protocols early in the review process and 

should cover the expected cost for the life of the protocol as long as progress is being

made on the research plan. Currently, protocols are being approved for multiyear

periods, but funded on a year-to-year basis. An appropriate accountability and 

monitoring system should be established to force corrective action or cancellation if 

progress on a particular protocol or in a particular study site is not being made. 

As already noted, the Work Group believes that it is important to distinguish between the primary and

secondary mission of the CTN as well as to distinguish both missions from funding issues. The Network

has established its own parallel funding and project approval structure. The Work Group believes that this

was a necessary step for the proper functioning of the Network because the considerations made in 

cooperative efforts of this kind could not be transferred to an outside body that was unfamiliar with the 

needed compromises. However, this justification does not apply equally to all aspects of the CTN mission. 

The Work Group believes that the secondary mission of the Network does not require a separate funding or

evaluation structure: Normal NIDA processes, including Program Announcements and targeted Requests 

for Applications (RFAs), can provide the necessary funding—even when the projects are to be conducted

within the CTN. Even within the primary mission of the CTN, some kinds of research could be understood

and fairly evaluated without a separate evaluation and funding structure. A good example is the training 

research initiative recently launched by NIDA’s Treatment Research Branch. This kind of research is 

central to the primary mission of the CTN. Some of the studies funded by this RFA could certainly be

conducted within the CTN. For that reason, within those topics relevant to the primary mission, the Work

Group believes that CTN funding should be primarily focused on PCTs and their impact and secondarily

on treatment modifications or contextual research that will logically lead to PCTs that may have good 

scientific, practical, and policy implications. 

A single or limited number of Coordinating Centers should be established to manage all 

stages of protocol training, implementation, and data monitoring. An independent

Coordinating Center should be selected through a competitive bidding process in close 

coordination with the CTN Steering Committee, and it should endorse the plans under the 

terms and conditions of the cooperative agreement. 

The Work Group believes that reliance on such a Coordinating Center, as is often the case in other multisite 

trials, will significantly enhance efficiency in the CTN without supplanting the authority and responsibility 

of the Principal Investigator in the study. This approach will free senior investigators in the Nodes from

burdensome administrative tasks and enable them and their CTP partners to focus their attention on

scientific issues, training, and dissemination. 

RECOMMENDATIONS RELATING TO DISSEMINATION AND DIFFUSION OF CTN 

MATERIALS, RESULTS, TRAINING MODULES, AND OTHER WAYS TO IMPROVE THE 

QUALITY OF TREATMENT AND PREVENTION 

To fulfill the CTN’s mission, planning and resources for dissemination should be

included in all protocol development and review, not left as a matter to be addressed 

after the fact. Principal Investigators and their CTP colleagues should identify and

address likely barriers to widespread adoption during the planning phase of a study, and

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 19 
they should test approaches to overcoming such barriers in the practical clinical trials 

supported in the CTN. NIDA should consider providing additional resources within its 

own operations and the CTN to promote broader dissemination of evidence-based 

treatments. 

Dissemination is an inherent purpose of the NIH, but it is remarkable how little is known about effective 

dissemination. Normally, documentation of dissemination involves the documentation of processes, not

outcomes. For example, NIDA regularly documents its publications, conferences, Web site hits, and so on. 

From time to time, NIDA has also documented whether consumers or clinicians are aware of or are 

satisfied with scientific materials produced by NIDA. All these steps are worthwhile, but the mission of the 

CTN is outcome-focused. The IOM report that led to the creation of the CTN is the source of its primary 

mission: To help bridge the gap between science and practice, so as to prevent and treat substance use 

disorders more successfully. As measured against that goal, documentation of dissemination processes 

cannot be considered adequate. 

Very little literature has been published on dissemination, and the Work Group notes with approval the 

considerable efforts of the CTN to summarize that literature. Unfortunately, this literature is relatively 

limited; often not experimental; rarely focused on substance use disorders or, more broadly, on behavioral

health; and is sometimes grim in its implications—often documenting what does not work more than 

providing clear guidance to what does work. Indeed, some of the methods known not to have a strong

influence on actual clinical practice are processes now being documented as forms of CTN dissemination. 

That does not mean that articles, presentations, manuals, or other formats of scientific information are 

unhelpful. Logically, it is necessary to successful dissemination: It is not possible to implement methods 

that one does not know exist. However, it is clear that information is rarely sufficient to make a practical 

difference in the lives of those suffering with the behavioral health problems NIDA is tasked to help solve. 

NIDA and other Institutes should consider new research initiatives that address barriers 

to dissemination of effective treatment interventions. 

The CTN strategic plan for dissemination identifies the issues fairly well, and the Work Group’s 

recommendations are more a matter of concurrence, emphasis, and focus on the areas outside of the CTN 

that NIDA might consider. The Work Group believes that this suggests a need for (1) new funding

initiatives in effective dissemination of evidence-based practices, (2) cooperation with other research

agencies to begin to close that knowledge gap, (3) research on dissemination within the CTN, (4) use of the

best available methods in CTN dissemination efforts, and (5) cooperation with other agencies in

dissemination programs. 

The extent of the need for new initiatives in evidence-based treatments has been recognized repeatedly in

the CTN development process so far. For example, when the CTN began to ask about which empirically

supported treatments to disseminate, it was quickly realized that no list of such methods exists, and no

agreement has been reached regarding how to define them. Other areas of health research are far more 

advanced in the development of evidence-based practice guidelines, clinical pathways, or empirical 

summaries of evidence. These are complex matters, involving professional infighting, theoretical 

disagreements, philosophy of science issues, methodological preferences, funding issues, political 

concerns, statistical arguments, and the like. 

NIDA should find ways―perhaps in cooperation with the Substance Abuse and Mental Health Services 

Administration (SAMHSA), NIMH, and NIAAA―to develop rapid, updateable, cost-effective, 

multidisciplinary, evidence-based ways to reach a broad consensus on lists of empirically supported

treatments, practice guidelines, or clinical pathways that can then inform the CTN’s PCTs and disseminate 

research within NIDA more generally. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 20 
The CTN should work closely with NIDA and other agencies working on dissemination,

especially SAMHSA’s Addiction Technology Transfer Centers (ATTCs) network. 

The dissemination efforts of the CTN should be leveraged wherever possible. The CTN dissemination 

strategic plan recognizes this clearly. Although NIDA has a direct dissemination mission, other

agencies―for example, SAMHSA’s Center for Substance Abuse Treatment (CSAT) and Center for 

Substance Abuse Prevention―are even more focused on this mission, and the CTN should work with these 

agencies to amplify the Network’s impact. The Work Group noted with satisfaction that NIDA is helping 

to fund dissemination efforts by CSAT’s ATTCs. NIDA should build on this opening and should ensure

that these efforts are evaluated or, in some cases (with NIDA cooperation and funding), formally 

empirically tested. 

The focus of dissemination can be expanded in other ways, as is noted in the CTN external linkages plan. 

The Work Group would add that it might also be possible for the CTN to involve more CTPs without

increasing costs, perhaps through the creation of a new category of CTPs that are informally linked to the 

CTN. Such “affiliate CTPs” perhaps could be linked to the ATTCs or to the CSAT Practice/Improvement 

Collaborative programs. Their primary purpose would not be involvement in PCTs, but involvement in

dissemination efforts of the CTN. 

Overall, the Work Group believes the CTN is making good headway in its dissemination plan, but that the 

Network will need help from NIDA at large to accomplish this mission more fully. 

NIDA and the CTN should establish a continuing collaboration with directors of State 

treatment and prevention agencies, perhaps through the auspices of the National 

Association of State Alcohol and Drug Abuse Directors (NASADAD), to foster dialogue 

about the CTN and NIDA research agenda and to enhance the probability of broad

dissemination of effective treatment regimens. 

The Work Group noted the successful initial meeting with a few State directors at the recent CTN program

in Denver and urges the Network and NIDA to continue efforts to nurture a strong relationship. The State 

directors can have a powerful influence on adoption rates for more effective treatments through their 

financial and regulatory oversight of the public treatment system. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 21 
VI. REFERENCES 

Crits-Christoph P, Siqueland L, Blaine JD, Frank A, Luborsky L, Onken LS, et al. Psychosocial treatments 

for cocaine dependence: Results of the National Institute on Drug Abuse Collaborative Cocaine Study. 

Archives of General Psychiatry 56:495-502, 1999. 

Lamb S, Greenlick MR, McCarty D (editors). Bridging the Gap Between Practice and Research: Forging 

Partnerships with Community-Based Drug and Alcohol Treatment (Washington, DC: Committee on 

Community-Based Drug Treatment, Institute of Medicine, National Academy Press), 1998. 

Margolin A, Kleber HD, Avants SK, Konefal J, Gawin FH, Stark E, et al. Acupuncture for the treatment of 

cocaine addiction: A randomized controlled trial. Journal of the American Medical Association 287(1):55-

63, 2002. 

Marijuana Treatment Project Research Group. Treating cannabis dependence: Findings from a multi-site 

study. Journal of Consulting and Clinical Psychology, in press. 

Project MATCH Research Group. Matching alcoholism treatments to client heterogeneity: Project

MATCH three-year drinking outcomes. Alcoholism: Clinical & Experimental Research 22:1300-1311, 

1998. 

Tunis SR, Streyer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for 

decision making in clinical and health policy. Journal of the American Medical Association 290(12):1624-

1632, September 24, 2003. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 22 
VII. APPENDICES 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 23 
APPENDIX A: CTN NODES 

Oregon Node

OHSU

Washington Node

U. Washington

Pacific Node

UCLA

Rocky Mountain Node

U. Colorado

Florida Node U. Miami

Great La Great Lakes Node

Wayne State U.

Ohio Valley N alley Node

U. Cincinna U. Cincinnati

South Caro uth Carolina No lina Node

MUSC

North Carolina Node

Duke

California/A ornia/Arizona Node

UCSF/U. Arizona

Southwest Node

U. New Mexico

Northern NE Node

McLean/Harvard

New England Node and Node

Yale New York Node

NYU

Long Is Long Island Node

NY State Psych. Inst.

Delaware Valley Node

U. Pennsylv U. Pennsylvania

Mid-Atlantic N lantic Node

JHU/MCV

Oregon Node

OHSU

Washington Node

U. Washington

Pacific Node

UCLA

Rocky Mountain Node

U. Colorado

Florida Node U. Miami

Great La Great Lakes Node

Wayne State U.

Ohio Valley N alley Node

U. Cincinna U. Cincinnati

South Caro uth Carolina No lina Node

MUSC

North Carolina Node

Duke

California/A ornia/Arizona Node

UCSF/U. Arizona

Southwest Node

U. New Mexico

Northern NE Node

McLean/Harvard

California/A ornia/Arizona Node

UCSF/U. Arizona

Southwest Node

U. New Mexico

Northern NE Node

McLean/Harvard

New England Node and Node

Yale New York Node

NYU

Long Is Long Island Node

NY State Psych. Inst.

Delaware Valley Node

U. Pennsylv U. Pennsylvania

Mid-Atlantic N lantic Node

JHU/MCV

Node Affiliation Primary Investigator 

California/Arizona University of California at San

Francisco 

James L. Sorensen, Ph.D. 

Delaware Valley University of Pennsylvania George E. Woody, M.D. 

Florida University of Miami José Szapocznik, Ph.D. 

Great Lakes Region Wayne State University Charles R. Schuster, Ph.D. 

Long Island New York State Psychiatric Institute Edward V. Nunes, M.D. 

Mid-Atlantic Johns Hopkins University School of 

Medicine

Maxine Stitzer, Ph.D. 

New England Yale University Kathleen Carroll, Ph.D. 

New York New York University School of 

Medicine

John Rotrosen, M.D. 

North Carolina Duke University Medical Center Robert L. Hubbard, Ph.D., M.B.A. 

Northern New England McLean Hospital Roger D. Weiss, M.D.

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 24 
Ohio Valley University of Cincinnati College of 

Medicine

Eugene Somoza, M.D., Ph.D. 

Oregon Oregon Health Sciences University Dennis McCarty, Ph.D. 

Pacific Region University of California, Los Angeles Walter Ling, M.D. 

Rocky Mountain University of Colorado School of

Medicine

Paula Riggs, M.D. 

South Carolina Medical University of South Carolina Kathleen T. Brady, M.D., Ph.D.

Southwest University of New Mexico William R. Miller, Ph.D. 

Washington University of Washington Dennis M. Donovan, Ph.D. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 25 
APPENDIX B: GENERAL CTN STRUCTURE DEFINITIONS 

The CTN is a collaborative group of geographically diversified Regional Research Nodes working 

collaboratively with NIDA to conduct multisite and cross-regional clinical trials on promising behavioral, 

pharmacological, or integrated treatments. 

NODES 

A Node is a functional unit within the CTN consisting of the Regional Research and Training Center 

(RRTC) and its affiliated Community Treatment Programs. The RRTC serves as the coordinating core and

promotes a bidirectional research partnership between the RRTC and the CTPs. There are currently 17

Nodes in the CTN. 

REGIONAL RESEARCH TRAINING CENTER (RRTC) 

The RRTC is the recipient of the cooperative agreement award. One of the two components of a Node, the 

RRTC resides in the Principal Investigator’s research and prevention institute or organization’s academic 

medical center. The Principal Investigators at these sites are recognized nationally and internationally as 

scientific experts in substance addiction treatment. The RRTC provides a core of administrative and study 

operations services as well as scientific leadership and management of clinical trials. 

COMMUNITY TREATMENT PROGRAMS (CTP) 

CTPs are drug abuse treatment programs in a community (typically non-university-based) setting that have

a history of providing quality treatment to large and diverse patient populations and that have the capability 

for and interest in participating in controlled clinical trials. There are currently 116 CTPs in the CTN. 

NIDA CENTER FOR CLINICAL TRIALS NETWORK (CCTN) 

The Center for Clinical Trials Network is located within NIDA’s Office of the Director and is responsible 

for the scientific, operational, administrative, and budgetary management of the CTN. There are currently 

17 full-time and part-time staff members, not including the Director. 

ADMINISTRATIVE AND LOGISTICAL SUPPORT 

NIDA awards contracts to provide centralized support for the administrative and logistical functions of the 

CTN. 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 26 
APPENDIX C: CTN PROTOCOL PORTFOLIO 

Protocol

Number Title Node 

Lead 

Investigator Start Date 

Complete 

Date 

AIDS/HIV Protocols 

CTN 0012 Characteristics of Screening, 

Evaluation, and Treatment of

HIV/AIDS, Hepatitis C Viral 

Infections, and Sexually

Transmitted Infections in 

Substance Abuse Treatment 

Programs (“Infections and 

Substance Abuse”) 

New York Lawrence 

Brown 

June 2003 4Q 2004 

CTN 0017 HIV and HCV Intervention in 

Drug Treatment Settings 

Rocky Mountain Robert Booth 1Q 2004 TBA 

CTN 0018 HIV/STD Safer Sex Skills 

Groups for Men in Methadone 

Maintenance or Drug-Free 

Outpatient Treatment

Programs 

Washington Donald

Calsyn

4Q 2003 TBA 

CTN 0019 HIV/STD Safer Sex Skills 

Groups for Women in 

Methadone Maintenance or 

Drug Free Outpatient 

Treatment Programs

Long Island Susan Tross 4Q 2003 TBA 

CTN 0024 Reducing HIV Risk Behaviors 

Among Adolescents in

Community-Based Substance 

Abuse Treatment Programs 

Long Island Jeffrey

Wilson 

TBA TBA

CBT Protocols 

CTN 0015 Women’s Treatment for 

Trauma and Substance Use 

Disorders 

Long Island Denise Hien 3Q 2003 4Q 2005 

CTN 0026 Treatment of Depression in 

Adult Substance Abusers 

South Carolina Susan Sonne TBA TBA 

Family Protocols 

CTN 0014 Brief Strategic Family

Therapy for Adolescent Drug 

Abusers 

Florida Jose

Szapocznik 

2Q 2003 2Q 2006 

CTN 0022 Family Management Skills for

Opiate-Addicted Women in 

Treatment: A Double Impact 

Risk Reduction Intervention 

Great Lakes Robert 

Zucker 

TBA TBA

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 27 
Protocol

Number Title Node 

Lead 

Investigator Start Date 

Complete 

Date 

Incentives Protocols 

CTN 0006 Motivational Incentives for 

Enhanced Drug Abuse 

Recovery: Drug-Free Clinics 

Mid-Atlantic Maxine

Stitzer 

26 Apr 2001 28 Feb 2003 

CTN 0007 Motivational Incentives for 

Enhanced Drug Abuse 

Recovery: Methadone Clinics 

Mid-Atlantic Maxine

Stitzer 

26 Apr 2001 28 Feb 2003 

Medication Protocols 

CTN 0001 Buprenorphine/Naloxone 

versus Clonidine for Inpatient 

Opiate Detoxification 

Pacific Walter Ling 26 Feb 2001 27 Feb 2002

(IRB) 

14 Aug 2002 

(DSMB) 

CTN 0002 Buprenorphine/Naloxone 

versus Clonidine for 

Outpatient Opiate

Detoxification 

Pacific Walter Ling 05 Jan 2001 27 Feb 2002

(IRB) 

14 Aug 2002 

(DSMB) 

CTN 0003 Suboxone 

(Buprenorphine/Naloxone) 

Taper: A Comparison of 

Taper Schedules

Pacific Walter Ling June 2003 3Q 2004 

CTN 0009 Smoking Cessation Treatment 

With Transdermal Nicotine 

Replacement Therapy in 

Substance Abuse 

Rehabilitation Programs 

New York Malcolm Reid 21 Apr 2003 3Q 2005 

CTN 0010 Buprenorphine/NaloxoneFacilitated Rehabilitation for

Opiod-Dependent 

Adolescent/Young Adults 

Delaware Valley George 

Woody

2Q 2003 3Q 2005 

MET/MI Protocols 

CTN 0004 MET (Motivational 

Enhancement Treatment) to

Improve Treatment 

Engagement and Outcome in 

Subjects Seeking Treatment

for Substance Abuse 

New England Kathleen 

Carroll 

30 May 2001 2Q 2003 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 28 
Protocol

Number Title Node 

Lead 

Investigator Start Date 

Complete 

Date 

CTN 0005 MI (Motivational 

Interviewing) to Improve 

Treatment Engagement and

Outcome in Subjects Seeking

Treatment for Substance

Abuse 

New England Kathleen 

Carroll 

12 Apr 2001 4 Oct 2002 

CTN 0013 Motivational Enhancement 

Therapy to Improve 

Treatment Utilization and

Outcome in Pregnant 

Substance Users 

Ohio Valley Theresa 

Winhusen 

2Q 2003 4Q 2005 

CTN 0021 Motivational Enhancement 

Treatment to Improve 

Treatment Engagement and

Outcome for SpanishSpeaking Individuals Seeking 

Treatment for Substance

Abuse (METS) 

New England Kathleen 

Carroll 

Jose

Szapocznik 

3Q 2003 TBA 

Services/Nontreatment Protocols

CTN 0008 Assessment of the National 

Drug Abuse Clinical Trials 

Network: A Baseline for

Investigating Diffusion of 

Innovation (“Baseline Study”) 

Oregon Dennis

McCarty

1Q 2002 3Q 2003 

CTN 0011 A Feasibility Study of a 

Telephone Enhancement 

Procedure (TELE) to Improve 

Participation in Continuing 

Care Activities 

North Carolina Robert 

Hubbard 

08 Jan 2003 4Q 2004 

CTN 0016 Patient Feedback: A 

Performance Improvement 

Study in Outpatient Addiction

Treatment Settings 

Delaware Valley Robert 

Forman

3 4Q 2003 TBA 

CTN 0020 Job Seekers Training for 

Patients with Drug 

Dependence 

Mid-Atlantic Dace Svikis 1Q 2004 TBA 

CTN 0025 Community Reinforcement 

and Family Training to

Increase Drug Abusers’

Motivation for Treatment 

Ohio Valley Greg Brigham TBA TBA 

12-Step Protocols 

CTN 0023 12-Step Facilitation as an 

Intervention to Increase 12-

Step Activities and Improve 

Outcomes among DrugDependent Individuals 

Washington Dennis

Donovan 

TBA TBA

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 29 
APPENDIX D: CTN BUDGET EXPENDITURES 

Fiscal Year

Number of 

Nodes

Number of 

New Nodes

New Awards

Continuation

Awards

Protocol-Specific 

Supplements

Total

1999 5 5 $11,000,000 $11,000,000

2000 11 6 $13,200,000 $11,000,000 $24,200,000

2001 14 3 $6,600,000 $23,550,000 $650,000 $30,800,000

2002 17 3 $5,100,000 $25,200,000 $6,800,000 $37,100,000

2003 17 0 $0 $25,500,000 $11,900,000 $37,400,000

 Totals: $35,900,000 $85,250,000 $19,350,000 $140,500,000

Projection 2004 17 0 $0 $25,500,000 $11,900,000 $37,400,000

CTN Budget Expenditures 1999 Through 2003

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 30 
APPENDIX E: CLINICAL TRIALS NETWORK WORK GROUP 

Work Group Members

David Rosenbloom, Ph.D., Chair 

Director, Join Together 

Boston University School of Public Health

441 Stuart Street, 7th Floor

Boston, MA 02116

(617) 437-1500

david@jointogether.org

Richard R. Bootzin, Ph.D. 

Professor of Psychology and Psychiatry

Department of Psychology

University of Arizona

1503 E. University Boulevard, Bldg. 68 

Tucson, AZ 85721

(529) 621-5705

bootzin@u.arizona.edu

Kathleen Burlew, Ph.D. 

Professor of Psychology 

Department of Psychology

University of Cincinnati 

Mail Location 0376

Cincinnati, OH 45221

Nancy Hamilton, M.P.A., CAP, CCJAP 

CEO 

Operation PAR, Inc. 

6655 66th Street North 

Pinellas Park, FL 33781 

(727) 545-7564

nhamilton@operpar.org

Steven C. Hayes, Ph.D. 

Department of Psychology/296 

University of Nevada, Reno

Mack Social Science, Room 314 

Reno, NV 89557 

(775) 784-6828 x2005

hayes@unr.nevada.edu

Yasmin Hurd, Ph.D.

Professor, Karolinska Institute

Department of Clinical Neuroscience 

Psychiatry Section 

Karolinska Hospital 

Stockholm, Sweden SE-171 76

+46.8.517.72.379

Ron Jackson, M.S.W. 

Executive Director 

Evergreen Treatment Services 

1700 Airport Way South

Seattle, WA 98134

(206) 223-3644

ronjack@u.washington.edu

Herbert D. Kleber, M.D. 

Professor of Psychiatry

Director, Division on Substance Abuse 

Columbia University 

1051 Riverside Drive, P.I. Unit 66 

New York, NY 10032

(212) 543-5570

hdk3@columbia.edu

Thomas R. Kosten, M.D.

Professor of Psychiatry and Medicine 

Yale University School of Medicine

Deputy Chief of Psychiatry 

VA Connecticut, Bldg. 35—151D

950 Campbell Avenue 

West Haven, CT 06516

(203) 932-5711 x7438

thomas.kosten@yale.edu

Curtis Wright, M.D., M.P.H. 

Executive Medical Director 

Purdue Pharma L.P.

One Stamford Forum

Stamford, CT 06901 

(203) 588-7414

dr.curtis.wright@pharma.com

Clinical Trials Network Coordinator 

Denise Pintello, M.S.W., Ph.D. 

National Institute on Drug Abuse 

Office of Science Policy and Communications 

6001 Executive Boulevard 

Bethesda, MD 20892 

Science Writer

Sarah E. Michaud

IQ Solutions, Inc. 

11300 Rockville Pike, Suite 901 

Rockville, MD 20852 

CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 31 
CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 32 

APPENDIX F: CTN WORK GROUP MEETING AGENDA FOR 

AUGUST 

National Institute on Drug Abuse 

Clinical Trials Network Work Group 

August 19-20, 2003

Marriott Gaithersburg Washingtonian Center 

9751 Washingtonian Boulevard 

Gaithersburg, MD 20878 

301-590-0044 

Day 1 – August 19, 2003

9:00 – 9:15 am NIDA’s Strategic Plan: The Role for the CTN

Nora D. Volkow, M.D., Director, NIDA

9:15 – 10:00 am Opening Remarks; Work Group Questions 

David Rosenbloom, Ph.D., CTN Work Group Chair 

10:00 – 10:30 am Overview of the CTN; Work Group Questions 

Betty Tai, Ph.D., CCTN Director 

10:30 – 10:45 am BREAK 

10:45 – 5:00 pm EXECUTIVE SESSION

10:45 – 11:00 am Clinical Trials Process at NCI 

11:00 – 12:00 noon Work Group Discussion

David Rosenbloom, Ph.D., CTN Work Group Chair 

12:00 – 1:15 pm LUNCH (on your own)

1:15 – 2:15 pm “Adopting Innovations Through the CTN: Using the 

CTN as a Platform for Services Research” 
CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 33 

Day 1 – August 19, 2003 (continued)

2:15 – 2:45 pm Work Group Discussion

David Rosenbloom, Ph.D., CTN Work Group Chair 

2:45 – 3:00 pm BREAK 

3:00 – 4:00 pm NIDA Research Related to the CTN Portfolio 

4:00 – 5:00 pm Work Group Discussion 

- Review the Day 

- Pose Questions

- Make Requests for Possible Staff Presentations on Day 2

David Rosenbloom, Ph.D., CTN Work Group Chair 

Day 2 –August 20, 2003

9:00 –12:00 noon EXECUTIVE SESSION 

9:00 – 9:15 am Genetics and the CTN 

9:15 – 10:30 am Addressing CTN Work Group Objectives

- Goals of Final Report 

- Implementation Steps 

- Additional Information Needs 

David Rosenbloom, Ph.D., CTN Work Group Chair 

10:30 – 10:45 am BREAK 

10:45 – 12:00 noon Addressing CTN Work Group Objectives (continued) 

- Timeline 

- Next Steps 

- Work Group Assignments

David Rosenbloom, Ph.D., CTN Work Group Chair 

12:00 noon ADJOURN
CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 34 

APPENDIX G: CTN WORK GROUP MEETING AGENDA FOR 

OCTOBER 

National Institute on Drug Abuse 

Clinical Trials Network Work Group 

October 7-8, 2003

Wyndham City Center 

1143 New Hampshire Avenue, NW 

Washington, DC. 20037

202-775-0800 

Day 1 – October 7, 2003 

9:00 – 9:20 am Opening Remarks; Summary of Current Status

David Rosenbloom, Ph.D., CTN Work Group Chair 

9:20 – 9:40 am NIDA’s Research Dissemination Efforts

Timothy P. Condon, Ph.D., Associate Director, NIDA 

9:40 – 10:00 am CTN’s Research Dissemination Efforts

Jack Blaine, M.D., CTN, NIDA 

10:00 – 10:15 am Work Group Discussion

David Rosenbloom, Ph.D., CTN Work Group Chair 

10:15 – 10:30 am BREAK 

10:30 – 5:00 pm EXECUTIVE SESSION

10:30 – 10:45 am Data Management System 

10:45 – 11:45 am Work Group Discussion

David Rosenbloom, Ph.D., CTN Work Group Chair 

11:45 – 1:00 pm LUNCH (on your own)

1:00 – 1:30 pm CTN Process 
CLINICAL TRIALS NETWORK WORK GROUP REPORT AND RECOMMENDATIONS 35 

1:30 – 2:30 pm Work Group Discussion

David Rosenbloom, Ph.D., CTN Work Group Chair 

 2:30 – 2:45 pm BREAK 

2:45 – 5:00 pm Work Group Discussion and Objectives

- Review the Day 

 Additional Information Needs 

David Rosenbloom, Ph.D., CTN Work Group Chair 

Day 2 – October 8, 2003 

9:00 –12:00 noon EXECUTIVE SESSION 

9:00 – 10:00 am Addressing CTN Work Group Objectives

- Goals of Final Report 

- Implementation Steps 

David Rosenbloom, Ph.D., CTN Work Group Chair 

10:00 – 10:15 am Follow-up Discussion

Betty Tai, Ph.D., CCTN Director 

10:15 – 10:30 am BREAK 

10:30 – 12:00 noon CTN Work Group Recommendations 

- Timeline 

- Next Steps 

- Work Group Assignments

David Rosenbloom, Ph.D., CTN Work Group Chair 

12:00 noon ADJOURN