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Update on Clinical Research

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This report responds to the first resolve of Resolution 309 (I-98), which asks "That our American Medical Association (AMA) report as part of its Clinical Research Summit activities on the need for a national clinical research agenda to establish resource allocation priorities." Resolution 309 (I-98) was introduced by the  Illinois Delegation and referred to the Board of Trustees.

The crisis looming over clinical research has been developing for many years, and a number of alarms have been sounded repeatedly. In 1996, the AMA Council on Scientific Affairs convened a major conference on clinical research, "Addressing the Future in a Changing Environment," with representation from government, academic, managed care, and other public and private sector perspectives. The focus of the conference, a summary report of which was published in the American Journal of Medicine,¹ was on the future of clinical research and the clinical investigator in an evolving health care system. Issues identified by the conference participants focused on workforce requirements; the movement away from medical specialties and clinical research; a declining number of physician investigators to serve as mentors for younger physicians in training; insufficient protected research time; and the role of increasing student debt in discouraging entry of future clinical investigators. Recommendations resulting from this conference were that a national summit of key stakeholders in clinical research to establish a robust clinical enterprise be held, that clinical research training be restructured to attract more clinicians; and that flexibility in use of funding be sought through legislative/regulatory changes. 

Following that conference, a mini-symposium on clinical research was conducted at the 1996 meeting of the AMA's Section on Medical Schools, which served as a springboard to Moskowitz and Thompson's editorial, "Preventing the Extinction of the Clinical Research Ecosystem."² In response to the challenge articulated in that editorial, the AMA, the Association of American Medical Colleges (AAMC), and Wake Forest University School of Medicine launched the National Clinical Research Summit project in the fall of 1997 to build a consensus on ways to respond to this crisis by all the stakeholders in clinical research. The tripartite executive committee, David Korn, MD, and Roger Meyer, MD, from AAMC; Reed V. Tuckson, MD, Myron Genel, MD, and Harry Jonas, MD, from the AMA; and Jay Moskowitz, PhD, and James Thompson, MD, from Wake Forest University, have guided the project with assistance of David Helms, PhD, president and CEO of the Alpha Center who served as facilitator for the focus groups and the Graylyn Consensus Development conference. 

In 1998, 10 focus groups of stakeholders, comprising a total of more than 175 individuals from government and corporate research funding agencies, private and public purchasers of health care, health plans and insurance companies, leaders and representatives of health care communities and academic health centers, pharmaceutical and medical device suppliers, patient advocacy groups, the bioethics communities, and others involved in clinical research met to identify the problems facing the clinical research endeavor and potential solutions as perceived from their specific vantage points.

In November 1998, 50 select representatives of the focus groups met at the Graylyn Conference center at Wake Forest University to build a consensus statement on problems and to develop a set of goals and objectives based on reports of each of the focus groups. In addition to the 10 summary documents from the 10 different focus groups, the participants were provided with a review of the origins of scientific medicine in the United States; various currently operative definitions of clinical research; data on major sponsors of clinical research in the United States; and a review of past recommendations and proposals to strengthen clinical research,   "The Changing Landscape for Clinical Research."³

A copy of the report of the Graylyn Development Consensus Conference is appended to this report.[Note: Not available on-line.] Crucial to this process was consensus on the definition of "clinical research." The Graylyn report articulates the operational definition of clinical research used for this process. In fulfillment of the mission of the project, goals and objectives, problems, and specific recommendations are presented in detail. The report correctly reflects the process and the views of the participants. 

The following is an overview of the Graylyn report. Nine problems were identified, the most important being the lack of clarity of what is meant by clinical research. An agreement on an adequate definition was an important step toward identifying additional problems and possible solutions. The Graylyn Consensus Conference definition of clinical research reads:

The definition will assist in a better understanding of the importance of clinical research by federal and private funding agencies, pharmaceutical and health care industries, patient advocacy groups and academic health center and other health care professionals. With an established definition, the stakeholders in the future of clinical research, particularly the public, can be engaged in a dialogue about the value of clinical research in the quality of health care and the need for its financial support. With more clarity of understanding of what is included in clinical research, its ethical underpinnings can be strengthened with appropriate protection for privacy and confidentiality of participants. Given such assurances, the public could be recruited to increase its participation. 

Lack of infrastructure within the academic health center (AHC) and insufficient funding for clinical research and researchers (cited by all health care professionals engaged in clinical research) were considered important problems. Recognition of a lack of adequately trained clinical investigators was balanced by recognition of lack of financial support for the entire continuum of activities subsumed under clinical research. How much is actually spent on clinical research is difficult to ascertain, and a need was identified to develop mechanisms to track and disseminate the aggregate levels of financial and other support for each of the major categories of clinical research. 

The AHC as the traditional site of clinical research is under challenge. Collaboration with managed care organizations and other components of the health care delivery system is required to broaden the base of clinical research, and accountability will be imperative if AHC are to fulfill a role in clinical research. This must be balanced by recognition of the continued important role that such centers have in training clinical investigators, and that they should be acknowledged by improved funding from federal agencies and other third party payers (including managed care organizations). 

A number of recommendations focused on the workforce issues: (1) the need for education of all health care professionals to enable them to contribute to the evidentiary base of their practices and disciplines; (2) the need for stipendiary support and career development, and the need for multi-disciplinary teams of population-based researchers; (3) the need to expand the scope and venues for clinical research to practice networks and managed care organizations; and (4) the need to engage more researchers from under-represented communities.

There was recognition that existence of meaningful data -- not simply limited to knowing how much is spent on clinical research -- is a critical issue. The lack of or inaccessibility of databases for patient and population-based health research is a hurdle to the success of clinical research endeavors and will require action both to protect patient privacy and ensure access for clinical research that impacts public health. Funding by the National Institutes of Health and other federal agencies could support modifications of existing patient databases in practice-based networks and integrated health systems to facilitate research. 

The Graylyn report also notes that underlying the identification of all of these problems, and the need for agreement on what constitutes the continuum of clinical research, is the lack of a comprehensive, dynamic national clinical research agenda. A Clinical Research Roundtable modeled after the successful Government, University, Industry Research Roundtable (GUIRR), could foster the development of such an agenda by identifying needs, establishing priorities, and monitoring progress.

The establishment of a Clinical Research Roundtable is in progress through discussion with the Institute of Medicine and the Commission on Life Science at the National Academy of Science, contingent on adequate fund raising. 

Up to 25 national leaders from the private, public, and professional sectors reflecting the diversity of responsibility for the conduct and application of clinical research would be convened to serve on a rotating basis. The Roundtable will allow the stakeholders to further identify and discuss the major barriers to the conduct of clinical research and approaches that might be employed to overcome them. From time to time, workshops or other public events will be convened to explore issues identified by the Roundtable participants. Selection of topics for the workshops will consider the timeliness of the issues, the amount of information already available on the topic, and whether or not the Roundtable can offer additional information or perspectives that would be useful to the discussion.

The Roundtable will meet up to four times each year for a three-year period. No more than 49% of the budget can come from parties that might have a financial stake in the Clinical Research Roundtable activities (Pharmaceutical Research and Manufacturers Association, insurance companies, AMA, AAMC) nor can more than 49% of the participants be such representatives. Fifty-one percent of the budget could come from government agencies. The projected first-year budget is $350,000 to $700,000. 

The final report of the Clinical Research Summit project is scheduled for release in early November 1999 at which time it is expected that the recommendations of the report will be unveiled as well as the announcement of the formation of the Clinical Research Roundtable. 

Relevant AMA Policy [Editor's Note: The following discussion reflects AMA policy at the time this report was written (Fall 1999).]

H-55.987 Viability of Cancer Clinical Research-Patient Accrual - recognizes and supports the leadership role of clinical oncologists (American Society of Clinical Oncology and the American Society for Therapeutic Radiology and Oncology) to encourage recruitment of patients to qualified investigators in clinical trials and greater involvement of community based physicians in peer review protocols. (CSA Rep G, A-89)

H-315.983 Patient Privacy and Confidentiality - AMA affirmation of key principles of patient privacy and confidentiality. (BOT Rep. A-98: Reaffirmed I-98)

H-460.926 Support of Biomedical Research Report   - Reaffirmation of long standing support for ample federal funding of medical research. (Sub. Res. 507, I-97)

H-460.930 Council on Scientific Affairs Conference: "Clinical Research: Assessing the Future in a Changing Environment" - States the AMA will be the principal advocate for clinical research, will promote the importance of this science and of well trained researchers to conduct it. (CSA Rep 2, I-96)

H-460.933 Clinical Research and the AMA - supports the principle that fundamental and applied clinical research is essential to provide the knowledge base for the practice of modern medicine. (Res 512, A-96). 

H-460.965 Viability of Clinical Research Coverages and Reimbursement - AMA believes that (1) third party payors should cover patient care costs of nationally approved (e.g. NIH, VA, ADAMHA. FDA) scientifically based protocols approved by nationally recognized peer reviews mechanisms. (Rep F, I-89, Reaffirmed : BOT Rep. I.93-40)

H-460.982 Availability of Professionals for Research. - major public and private research foundations should consider the research opportunities in the biomedical sciences& 

H-460.986 Financial Protection for Clinical Research  - [Clinical research] should be adequately funded by both public and private sources. (CMS Rep. A, I-86; Reaffirmed: I-96)

H-460.998 Support of Biomedical Research - AMA endorses and supports ten principles considered essential if continuing support and recognition of biomedical support vital to the delivery of quality medical care is to be a national goal. (CLRPD Rep C, A-89).

H-460.999 Support of Continued Government Funding of Basic and Applied Clinical Research - AMA reaffirms its interest in promoting research and supports restoration and continuation of government funds for basic and applied clinical research.   (CLRPD Rep C, A-89)

H-460.990 The Transfer of Technology   - All providers, payors, manufacturers, health care facilities, governmental units, and consumers of health care have an obligation to contribute to an orderly process of technology diffusion.   (BOT Rep NN, A-87; Reaffirmed, I-97).

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy at the 1999 AMA Interim Meeting.

1. The AMA supports the findings of the National Clinical Research Summit as developed at the Graylyn Consensus Development Conference, November 20-22, 1998;  
2. The AMA actively supports the establishment of the Clinical Research Roundtable as a component of the National Academy of Sciences/Institute of Medicine and Commission on Life Science; and  
3. The AMA reaffirms policies H-55.987, H-315.983, H-460.926, H-460.930, H-460.933, H-460.965, H-460.982, H-460.986, H-460.998, H-460.999, and H-460.990. 

References

1. Meyer M, Genel M, Altman RA, Williams MA, Allen JR. Clinical Research. Assessing the future in a changing environment : Summary report of conference sponsored by the American Medical Association Council on Scientific Affairs, Washington, DC, March 1996. Am J Med. 1998:104: 264-271.  
2. Thompson JN, Moskowitz J. Preventing the extinction of the clinical research ecosystem. JAMA. 1997;278:241-145.   
3. Heinig S, Quon ASW, Meyer R, Korn D. The changing landscape for clinical research, Academic Medicine. 1999:74:725-745. 

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