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Statement by David Korn, M.D.
Association of American Medical Colleges
November 15, 1999Clinical Research: A National Call to Action
I would like to begin this presentation with a personal observation. The Graylyn consensus conference was one of the most intellectually stimulating, but at the same time, exhausting meetings that I have ever taken part in. As facilitator David Helms and I waited for our flight back to Washington, we both had the fixed, glassy-eyed stares of survivors, yet both of us were elated by what had been accomplished in a weekend of very hard work conducted in an atmosphere of remarkable comity.
The business of the conference began with the relatively rapid adoption of the Mission Statement, and then turned to something deceptively simple: a definition. What is Clinical Research? Over the years, various groups, committees and distinguished authors have wrestled, sometimes bitterly, with this question and proposed different definitions, but these efforts have consistently failed to win universal acceptance. Without a widely understood definition, it becomes virtually impossible to have a national conversation about clinical research or agree on a national agenda for action. Without a shared definition of clinical research, it becomes virtually impossible to enlist the participation of all the diverse sectors of the health care enterprise, or communicate the importance and value of clinical research to the public. Not surprisingly, therefore, Summit participants identified this issue as the first of nine core problems that confront clinical research today.
The definition of clinical research found in the Summit's Call to Action is deliberately comprehensive and inclusive - perhaps the best description is hospitable - and it recognizes all the interconnected pieces that together make up the coherent body of science that we call clinical research. The definition is both synthetic and analytic: it encompasses such areas as translational research (in which basic laboratory findings are first "translated" into clinical applications), clinical trials, research in behavior, disease prevention and health promotion, as well as epidemiology and health services research. But at the same time, it identifies the separate subcomponents that make up clinical research, and allows attention to each and any one of them as integral parts of a broad national clinical research agenda.
Armed with this clearly stated definition, Summit participants moved next to address a related problem: clinical research is not adequately understood or valued-by the public, the government, or even by the stakeholder groups themselves. Nowhere is this more evident than in the agonizingly slow pace and low levels of recruitment for clinical trials. A recent survey by the American Society for Clinical Oncology reported that fewer than four percent of eligible cancer patients participate in clinical trials. A recent New York Times front-page story described the difficulty scientists faced in finding participants for autologous bone marrow transplant trials for ovarian and breast cancer. The ovarian cancer trials fell apart after doctors at more than 100 institutions spent two and a half years seeking 285 women to participate, only to be able to enlist fewer than 30. The breast cancer trials ultimately did go forward-but it took seven years - 7 years - to recruit the 1,000 women needed for the studies.
We in the health sciences community do not absolve ourselves of responsibility in this arena. Over the last several decades, the promise-and the reality-of basic biomedical research has been so exciting, so captivating that it has received the lion's share of attention from scientists, consumer groups, policymakers, the public, and, yes, academic health centers. But the fact is that without a robust and well-balanced clinical research enterprise, much of what we learn through basic research cannot be applied effectively and efficiently to advancing the health of the public. And improving the public's health is what biomedical and health sciences research is ultimately all about!
As the Call to Action notes, clinical research is the neck of the scientific bottle, through which all basic discoveries must pass in order to be transformed into cures, therapies, preventions, interventions, and other strategies that benefit the public health. For example, the Human Genome Project alone is projected to spark an unprecedented increase in the number of targets for drug innovation-from approximately 500 known in 1996 to anywhere between 3,000 and 10,000 when the project is completed, perhaps as early as next year. How will these targets be evaluated, these drug innovations reach the public, and their medical and cost effectiveness be established? Only through clinical research-by passing through "the neck of the bottle," a neck that the Summit declares must be widened.
A first step toward rectifying the lack of public understanding of the importance of clinical research is the broad adoption of the Summit's shared definition.
A second critical step in enhancing public understanding focuses on strengthening and protecting the public's trust. The Summit calls for reaffirmation and recommitment to the ethical foundations of clinical research. We must strengthen our protection of human subjects, expand training in the ethical underpinnings of clinical research, and promote a wide-ranging public dialogue that improves public understanding and confidence in clinical research. This dialogue must take place across our society, but it is particularly important with regard to population groups that have been subject to research abuses, such as the African-American community.
The lack of a definition and lack of understanding of clinical research contribute to the third problem identified by the Summit: an absence of systematic data on funding of clinical research, and on how productive that research is once it is funded. If we cannot agree on what we mean by "clinical resaerch," how can we speak intelligently about adequacy of funding or returns on investments? The broad definition proposed by the Summit participants should help to address this "data gap." The expansive perspective of the definition allows for broad monitoring of the enterprise as a whole, while at the same time, the individual components can be identified for more specific tracking of opportunities, problems and needs.
The question of investment is at the core of the fourth problem identified by the Summit participants: insufficient funding for some types of clinical research, such as translational research, some types of clinical trials, and population-based research related to health services, epidemiology and prevention. While Congress and the Administration have responded remarkably to the promise of biomedical research over the past few years with dramatic expansion of funding for the NIH, there has been less attention and support for health services research and the development of strategies for disease prevention. Agencies like the CDC, the soon to be renamed AHCPR, the Department of Veterans Affairs, and the FDA are vital elements of a cohesive clinical research enterprise, but their funding continues to lag behind. Congressional appropriations reflect public enthusiasm for biomedical research, and if we can improve the public's understanding of the vital role that clinical research plays in bringing treatments, cures, and prevention to the community and establishing their effectiveness, we do not doubt that public support for additional clinical research funding will become equally enthusiastic.
The inclusiveness of the Summit definition of clinical research should help to create a broad national alliance for clinical research that cuts across and enlicits participation from all sectors of the health care enterprise. The definition should also serve as the foundation for a new, federal-private sector-academic partnership that will be necessary to promote the funding and development of broad-based and expensive infrastructure needs that cut across all sectors, and whose development will only result from concerted, cooperative effort. An excellent example is the need for enhanced clinical information systems to monitor, evaluate, and respond to the needs of the broad spectrum of clinical research, to enable research institutions to better manage and assess their clinical research efforts and meet heightened public and private expectations of accountability, and to strengthen the evidentiary knowledge base of medical practice.
With an underfunded system of clinical research, it should come as no surprise that there is also an insufficient number of clinical investigators. There is a pressing need to expand the total number of physician-investigators, and especially M.D. clinical investigators. Physician investigators may participate in all aspects of clinical research, but their role in certain components of clinical research is not only essential but irreplaceable. We commend NIH for its recent decision to strengthen its institutional training programs and clinical research awards-I refer specifically to the new K series of awards-as well as the targeted initiatives recently undertaken by several foundations. But workforce development is everyone's problem. Federal funders, foundations, academic health centers, and the health system as a whole must pay more attention to this issue and develop processes to monitor and promote workforce career development across the spectrum of clinical research and across the health professions.
We believe it is urgent that particular attention be paid to the recruitment and retention of underrepresented minority scientists. The number of minorities entering medicine is, tragically, in decline, which in turn means fewer minority physicians and scientists pursuing clinical research. We know that when more women began entering medicine, research into issues of importance to women's health increased substantially and continues to do so. If we expect to serve the health care needs of our nation's minority populations and meet the goals of the "Healthy People 2010" initiative, we need the contributions of minority scientists and minority physicians.
The Summit participants also agreed that insufficient attention has been paid to incorporating clinical research findings into clinical practice. Integrated health systems and practice-based networks offer rich potential for the kinds of population-based research in "real world settings" that form the foundation of evidence-based medicine. The Summit recommends a number of strategies to take advantage of these opportunities, including promoting mixed academic and non-academic clinical trials, and creating incentives that encourage collaboration in clinical research among academia, industry, private health providers, and managed care.
Collaboration is at the heart of the seventh problem area identified by the Summit: inadequate coordination of clinical research among research entities and disciplines. The history of biomedical research has been highly centered on individual disciplines and has promoted the development of a research culture characterized by what have been described as "separate silos," rather than an interconnected and interactive whole. But in recent years, the growth in basic biomedical capability and complexity has begun to break down these "silos" and demand multidisciplinary organization and cooperation. The same is true of clinical research. If we are to keep basic biomedical discoveries flowing through the neck of the scientific bottle into real-world practice, collaboration is essential. The General Clinical Research Center program of the NIH offers an excellent model, and the Summit recommends that it be expanded and that academic medical centers look to it as a model in establishing policies that foster interdisciplinary research. If the collective effort evoked by the Summit process is any barometer, it appears that the health care community has a powerful interest in greater collaboration.
A very substantial share of the nation's biomedical research agenda and almost all of its research training take place in the medical schools, other health professions schools and teaching hospitals of academic health centers-and anything that jeopardizes these institutions puts the future of clinical research in danger as well. Anyone who's read the newspapers over the last six months knows that America's academic health centers are at risk. The dramatic alteration of the health care delivery system coupled with multi-year reductions in federal medicare payments are producing a massive financial squeeze on the nation's teaching hospitals and undermining the foundations of their support for teaching, research and care of the most vulnerable members of our society. Particularly at risk in this turbulent environment is the physician investigator, whose career requires frequent and easy passage between the laboratory and patient care settings that are conducive to scholarship and research. If the clinical research agenda at our nation's medical and other health professions schools and their affiliated teaching hospitals is to thrive, the Summit participants agreed that the federal government should be cognizant of the financial health of academic health centers and be prepared to help protect and sustain their capacity to conduct clinical research and training.
Finally, the Summit participants noted that for years we have been navigating without a compass or a road map: we lack a comprehensive, balanced, dynamic agenda for clinical research. In order to define and pursue this agenda effectively, we need a standing structure-a visible, credible, and broadly representative entity that will focus ongoing national attention on the needs, opportunities, priorities, and progress of clinical research. Dr. Stobo will tell you more about how this standing group will be created. It will use the Call to Action as a starting point and guideline for establishing that shared agenda and promoting the understanding that clinical research is everyone's responsibility, everyone's opportunity, and for everyone's benefit.
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