Summary of the June 2000 Meeting of the Clinical Research Roundtable

Frederick J. Manning

Senior Program Officer, Institute of Medicine

Abstract. The 28-member Clinical Research Roundtable (CRR) consists of individuals from a broad range of government, commercial, academic, and non-profit institutions that will gather quarterly for the next 3 years to discuss the challenges facing clinical research. Its June 27–28 meeting was partly organizational in nature, as the members discussed their interests and priorities for future work. The centerpiece of the meeting was a mini-symposium in which several invited speakers helped the CRR explore some of the difficulties involved in attracting, training, and sustaining clinical investigators. The group concluded by forming four subgroups to explore potential activities in the areas of data collection, the current and evolving clinical research process, career development, and public involvement in clinical research.

The Institute of Medicine (IOM) Clinical Research Roundtable (CRR) held its initial meeting on June 27–28, 2000, at the Ronald Reagan Building and International Trade Center in Washington, D.C. The group, chaired by Dr. William Gerberding, President Emeritus of the University of Washington, consists of individuals from the academic health community, federal agencies sponsoring and regulating clinical research, private – sector sponsors of clinical research, foundations, public–sector and private–sector insurance programs, health plans and insurance companies, corporate purchasers of health care, and representatives of patient interests. The roundtable will meet quarterly for the next 3 years to discuss the challenges facing clinical research and ways to create a more supportive environment for the conduct of a broad agenda of high–quality clinical research. The roundtable will provide a forum for discussion's about approaches to resolving both acute and long-term issues affecting clinical research and will sponsor workshops on these issues. The roundtable aims to enhance mutual understanding of clinical research within the scientific community and the general public, and to increase public participation in clinical studies. The charge to the group from IOM also calls on the CRR to be attentive to the ethical underpinnings of clinical research as it considers a broad range of workforce and infrastructure-related issues that span the full spectrum of clinical research.

The June meeting was primarily organizational in nature, as the 28 members learned about each other's backgrounds and experiences and explored their interests and priorities for future work by the CRR. IOM President Kenneth Shine set the stage for much of the meeting by pointing out that the Roundtable is both a fact-finding activity and a dissemination activity, and that it faced two big challenges in proceeding on its important mission. The first of those stems from the fact that, unlike typical IOM committees formed to answer very specific questions, roundtables are formed to gather together major stakeholders in a field, in this case the clinical research enterprise. He reinforced the need for the participants to put aside parochial biases or subordinate them to the public good. The second challenge, according to Dr. Shine, is to focus attention on two to four main topics out of the plethora of issues identified by previous groups assembled by IOM



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Summary of the June 2000 Meeting of the Clinical Research Roundtable Summary of the June 2000 Meeting of the Clinical Research Roundtable Frederick J. Manning Senior Program Officer, Institute of Medicine Abstract. The 28-member Clinical Research Roundtable (CRR) consists of individuals from a broad range of government, commercial, academic, and non-profit institutions that will gather quarterly for the next 3 years to discuss the challenges facing clinical research. Its June 27–28 meeting was partly organizational in nature, as the members discussed their interests and priorities for future work. The centerpiece of the meeting was a mini-symposium in which several invited speakers helped the CRR explore some of the difficulties involved in attracting, training, and sustaining clinical investigators. The group concluded by forming four subgroups to explore potential activities in the areas of data collection, the current and evolving clinical research process, career development, and public involvement in clinical research. The Institute of Medicine (IOM) Clinical Research Roundtable (CRR) held its initial meeting on June 27–28, 2000, at the Ronald Reagan Building and International Trade Center in Washington, D.C. The group, chaired by Dr. William Gerberding, President Emeritus of the University of Washington, consists of individuals from the academic health community, federal agencies sponsoring and regulating clinical research, private – sector sponsors of clinical research, foundations, public–sector and private–sector insurance programs, health plans and insurance companies, corporate purchasers of health care, and representatives of patient interests. The roundtable will meet quarterly for the next 3 years to discuss the challenges facing clinical research and ways to create a more supportive environment for the conduct of a broad agenda of high–quality clinical research. The roundtable will provide a forum for discussion's about approaches to resolving both acute and long-term issues affecting clinical research and will sponsor workshops on these issues. The roundtable aims to enhance mutual understanding of clinical research within the scientific community and the general public, and to increase public participation in clinical studies. The charge to the group from IOM also calls on the CRR to be attentive to the ethical underpinnings of clinical research as it considers a broad range of workforce and infrastructure-related issues that span the full spectrum of clinical research. The June meeting was primarily organizational in nature, as the 28 members learned about each other's backgrounds and experiences and explored their interests and priorities for future work by the CRR. IOM President Kenneth Shine set the stage for much of the meeting by pointing out that the Roundtable is both a fact-finding activity and a dissemination activity, and that it faced two big challenges in proceeding on its important mission. The first of those stems from the fact that, unlike typical IOM committees formed to answer very specific questions, roundtables are formed to gather together major stakeholders in a field, in this case the clinical research enterprise. He reinforced the need for the participants to put aside parochial biases or subordinate them to the public good. The second challenge, according to Dr. Shine, is to focus attention on two to four main topics out of the plethora of issues identified by previous groups assembled by IOM

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Summary of the June 2000 Meeting of the Clinical Research Roundtable and others. He advised the CRR to identify some important messages and the audiences that need to hear them before deciding on the nature of its products. RECAPPING THE GRAYLYN REPORT Dr. David Korn of the Association of American Medical Colleges (AAMC) began the open portion of the meeting with a brief overview of the Graylyn Report, product of the Clinical Research Summit Project, which is a joint effort of the AAMC and the American Medical Association in collaboration with Wake Forest University School of Medicine. The project organized and conducted 10 focus groups involving more than 150 representatives of public–sector and private–sector groups and institutions involved in clinical research in the fall of 1998; followed by a conference that eventually reached consensus on a definition of clinical research, nine important problems, and a set of goals and objectives designed to strengthen clinical research. Dr. Korn described only a few of the report's many valuable observations, one of which called for the creation of “a national mechanism, such as a ‘Clinical Research Roundtable' to identify needs, establish priorities, and monitor progress in clinical research.” Dr. Korn also called the group's attention to one of the problems identified by the report that would emerge repeatedly in the day's discussions: that the ability of academic health centers (AHCs) to conduct clinical research is at risk. Dr. Louis Sherwood of Merck & Co., Inc., added to the discussion of Dr. Korn's second point by comparing and contrasting the approaches in academia and industry to training clinical researchers and operating a clinical research program. For example, tightly integrated “project teams” of physicians and scientists do the work in industry and tend to be more focused on team goals and the overarching need for efficiency than on personal motivations and interests. Expertise is shared across groups, and a multidisciplinary approach is expected, with teamwork being the norm. Research funding is not the major limitation that it often is in academia, although aggressive timetables and cost control are expected in industry. Job growth and employee development is built into the industry model, including regularly scheduled reviews and mentoring. Other discussants pointed out that the members of the CRR were familiar with most of the points raised in the Graylyn Report and should really concentrate on new angles and inputs that could reach a broader audience. The discussion ended with the reminders that there is little in the way of solid data to support many of the assertions and suggestions that had been voiced during the day, and that one of the Graylyn Report's suggested goals was to establish mechanisms to track support for all the various types of clinical research. That provided an ideal segue to a report on some preliminary investigation by the IOM staff into possible sources of such data. Preliminary Thoughts on Data Collection Dr. Rick Manning began by reviewing the results of a preliminary inquiry to 25 AHC executives by IOM staff, with the aid of Dr. Tony Mazzaschi at AAMC and Dr. Roger Bulger at the Association of Academic Health Centers. The object of the inquiry was to

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Summary of the June 2000 Meeting of the Clinical Research Roundtable determine if it would be possible and, if so, how difficult it would be to collect data from the files of institutional review boards (IRBs) on the number and types of clinical research projects being conducted at AHCs, using the nine categories of clinical research included in the Graylyn Report's definition. These are categories: disease mechanisms; “translational” research (bed to bench, and bench to bed); clinical knowledge, detection, diagnosis, and natural history of disease; therapeutic interventions (drugs, biologics, devices, and instruments); prevention and health promotion; behavioral research; health services research, including outcomes; epidemiology; and community-based and managed care-based trials. Only four respondents indicated that their IRBs had such data or could retrieve such data. Furthermore, only one other institution reported categorizing their protocols in an approximation of the Graylyn categories; several institutions noted that their IRB review proposed research rather than funded projects. Dr. Manning's conclusion was that IRB records were unlikely to be useful for a retrospective data collection effort. Dr. Korn pointed out that there is legislation underway in Congress that will mandate some national oversight of IRBs, possibly including periodic reports, which might provide a mechanism for collecting the desired data in the future. Dr. William Crowley and his colleagues at Massachusetts General Hospital (MGH) took quite a different approach when they recently sought data on the number and types of clinical research projects being performed at their institution (Taylor et al., “An Estimation of NIH Revenues Supporting Clinical Research at the Massachusetts General Hospital: Techniques for Evaluation and Varying Definitions,” unpublished manuscript, 2000). Instead of relying on MGH databases, they went to the publicly accessible and searchable NIH database describing all funded grants (CRISP), selected the grants to MGH, and used the abstracts to categorize the work as physiology/pathophysiology, clinical trial, translational, outcomes, or epidemiological. Agreement among the categorizers was extremely good, as was agreement with the Principal Investigators, who were contacted and asked to categorize their own studies. Dr. Manning suggested that this might be a feasible approach, even if it was limited to NIH (or federal) grants. Kenneth Getz from CenterWatch volunteered that his organization had a great deal of experience with collecting data from industry–sponsored trials, and that they might be able to cover a lot of the remaining research. A working group will further explore what kind of and how much data are potentially available and make some recommendations to the CRR on whether and how to proceed. INVITED TALKS ON THE CLINICAL INVESTIGATOR WORKFORCE The afternoon mini-workshop involved a preliminary exploration of the clinical investigator workforce, requirements for a successful career, and obstacles facing potential clinical investigators. Dr. Crowley opened the session with an informative description of the allegedly endangered Clinicus investigatorus. He differentiated three species of C. investigatorus—population-oriented, patient-oriented, and bench-oriented—and used a succinct matrix to point out how the three differ in approach, material, infrastructure required, education, goals, sources of funding, academic promotion potential, and wish lists. The three types of clinical researchers all face five high hurdles, according to Dr.

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Summary of the June 2000 Meeting of the Clinical Research Roundtable Crowley: large debts upon completing professional training, a late start in research because of the length of clinical training, the low prestige of clinical research at AHCs, a lack of extensive systematic training in research techniques, and an ever-increasing burden of regulation and monitoring. In closing, he noted that that one key to success for translational researchers like himself is more and better collaboration among astute clinicians, clinical investigators, and basic scientists. Dr. David Kaufman of the University of North Carolina at Chapel Hill, former president of the Federation of American Societies of Experimental Biology (FASEB), told the group about a recently completed FASEB study on physician-scientists (Zemlo et al., The physician-scientist: Career issues and challenges at year 2000, The FASEB Journal 14:221–230, 2000). The authors drew on a wide variety of sources in gathering data that document some of the hurdles that were cited by Dr. Crowley in his talk—diminishing numbers of young physician-scientists and high debt levels faced by medical school graduates, for example. The report contains recommendations for improving the appeal of research to medical students, encouraging postgraduate research training by a program of debt forgiveness, expanding financial support for training and mentoring, improving the prestige of clinical research in AHCs, and gathering additional data with which to evaluate corrective actions. Dr. Dan Foster of the University of Texas Southwestern Medical Center also focused on physician-scientists, but he began by asserting that in his view, clinical research was becoming more popular as a career choice and laboratory research less so, even though there are still not enough laboratory researchers. He claimed that the reasons for this decline stem from three sources or issues, which he called plausibility structure, magnetism, and sociology. By plausibility structure, he meant that medical students come to medical school because they want to be clinicians (i.e., they are predifferentiated). The small group that comes to learn to do science finds that they are in an environment that values the results of science but not the scientific process. Successful physician-scientist role models are often invisible to medical students or stick out by virtue of their poorly maintained clinical skills, and they are therefore unattractive to the majority of students. As a result, the impulse to do science withers away even when it is initially present. By magnetism, he means that taking care of patients is immediately rewarding, and most students and junior faculty will back away from anything that threatens patient care. Successful physician-scientists do not seem happy and do not seek out and encourage students, who buy into the currently popular notion that you can only do one thing well. Finally, Dr. Foster refers to the sociology of physician-scientists. Students are often repelled by the big business mentality and large egos of successful physician-scientists who make their followers miserable and to whom mentoring too often means “make a clone of me.” Dr. Jules Hirsch of The Rockefeller University presented the case for the great importance of “bedside inquiry.” That is to say, he espouses a “continuum of therapy through research ” where information gathered by intelligent patient interactions supports and guides bench research and vice-versa. In recent years, the emphasis has been on the path from laboratory to bedside, and the equally important reverse path from bedside to laboratory is in danger. Dr. Hirsch sees biomedical research not as a linear process, but as a network with many nodes, a very important one of which is the physician at a bedside wondering how to understand a clinical phenomenon. The ideas that this is not what physicians do these days and that science takes place in laboratories suggest that medicine is

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Summary of the June 2000 Meeting of the Clinical Research Roundtable no longer a profession, but merely a technology. He does not believe this is the case and has been instrumental in founding the Association for Patient-Oriented Research to nurture the sort of bedside-to-bench interactions typified by his own work on the causes of obesity and the multiple differences between obese and normal-weight individuals. His suggestions for encouraging these observant clinicians include building some time into medical school faculty schedules for thinking and avoiding “overprotocolization.” COMMENTS ON THE CLINICAL RESEARCH WORKFORCE BY ROUNDTABLE RESPONDERS Dr. Adrian Dobs of Johns Hopkins focused her remarks on the obstacles facing the clinical trialist and steps her institution has taken to overcome them by means of a centralized clinical trials office. A survey of clinical investigators at Hopkins found that the major obstacles reported were lack of time for research, inadequate space and personnel, obtaining peer-reviewed funding, high institutional costs, difficulty recruiting patients, and a sense that clinical research was not a good route to advancement. It is widely believed that many of these factors have contributed to a decline in support for industry-sponsored trials as well. She argues for—and the Johns Hopkins Central Clinical Trials Office has begun—development of positions and staff to facilitate clinical research across departments, and centralization of common tasks like patient recruitment, staff training, and assuring regulatory compliance. An additional major hurdle is convincing the deans to recognize the importance of industry-sponsored trials, outcomes research, and other steps involved in turning basic science insights into improved health care. Dr. Veronica Catanese of New York University seconded Dr. Foster's observation that medical students seem to be less interested in research careers in recent years. They don not want to devote their whole life to the lab, she said, but see no middle ground that will allow them to both be successful and balance their clinical, educational, and research interests. She suggested that if one must specialize to succeed, perhaps the solution lies in teamwork rather than isolation. Although she praised the NIH K-series awards supporting clinical research training for physicians, she wondered whether the number of awards in coming years would increase in response to the increased number of applications. Similarly, she asserted that funding for the General Clinical Research Centers where many of these physician-scientists work had not kept pace with increase in total NIH appropriations. Dr. Lewis Sandy, executive vice president of the Robert Wood Johnson Foundation, offered several observations on the day's presentations. First, he noted that three issues implicit in much of the discussion need to be made explicit. One is the question of whether the focus should be on academic health centers or on clinical research as a whole. Related to that is whether the driving force should be facilitating commercial applications or fostering scholarly investigation. And third, he asked whether we should be pursuing incremental reforms or discontinuous changes (e.g., new IRB duties or a whole new approach to protecting subjects). Dr. Sandy also pointed to several new important issues related recruiting, training, and retaining clinical researchers: the nature and quality of the training, the recent surge in patenting, and the need to identify both existing “best practices” and

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Summary of the June 2000 Meeting of the Clinical Research Roundtable areas in which changes may well make things worse. Finally, he asked the group to think about the role(s) that private foundations might play in this arena. The final speaker of the day, Dr. Harold Slavkin, director of the National Institute of Dental and Craniofacial Research, pointed out that much the cutting-edge research currently being done involves new technologies that are dependent on physicists, engineers, and computer scientists. The training (and practice) of clinical researchers does not sufficiently prepare them for this dependency, nor does it recognize the flexibility demanded by the speed with which information and technology becomes obsolete. At the other end of the technology spectrum, he noted, we must recognize that many poor people have no contact with organized health care at all. Remedying the many existing disparities in health care will demand a different kind of clinical research, certainly one that includes a heavy emphasis on health promotion and disease prevention. Who will do that research? The general discussion of the issues raised by the speakers was wide-ranging and spirited, but ended as the day began—with a focus on the public. Dr. Elaine Larson of Columbia University urged her colleagues on the roundtable to focus on what needs to be done for the public, not on what researchers need. If we can identify and advance the former, she said, the latter will follow. FUTURE WORK Several hours of spirited discussion during Tuesday's executive session, aided by a stimulating talk by Yale University 's Richard Lifton on the implications of mapping the human genome for clinical research, led to agreement on four major areas to be explored in (and between) future meetings of the roundtable and to the establishment of four working and planning groups to spearhead work in those areas. A Data group will explore the feasibility and mechanics of collecting data with which to assess and monitor investments in clinical research and the clinical research workforce. A Public Confidence group will explore patient and public interest in and understanding of clinical research. A Mapping/Models group will attempt to describe the currently dominant model of biomedical research, from initial observations and basic research to incorporation into practice, and to explore new models for doing clinical research in an era of genomics, massive health plan databases, and globalization. A Career Development group will explore ways to recruit, train, and sustain clinical scientists in the various disciplines required. The Clinical Research Roundtable will meet again in Washington, D.C., on September 25–26 at the National Academy of Sciences.