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Update of Activities of the Clinical Research Roundtable NOTE: This report represents information on this subject as of June 2001. Full Text The Clinical Research Roundtable In response to the report Clinical Research: A National Call to Action, and requests from the American Medical Association (AMA) and numerous other sponsoring agencies and organizations, the Institute of Medicine (IOM) and the Commission on Life Sciences at the National Academies convened a Clinical Research Roundtable (CRR) early in the year 2000. The CRR has brought together individuals from the academic health community, federal agencies sponsoring and regulating clinical research, private sector sponsors of clinical research, foundations, public and private sector insurance programs, health plans and insurance companies, corporate purchasers of health care, and representatives of patient interests to discuss the challenges facing clinical research and the approaches that might be followed to create a more supporting environment for a broad agenda of high quality clinical research. Chaired by William Gerberding, PhD, President Emeritus, University of Washington, the Roundtable is composed of 28 members and 4 liaisons. Myron Genel, MD, Past Chair and current Council on Scientific Affairs (CSA) member, represents the AMA on the Roundtable. Information on membership and other activities of the CRR is available on its Web site. This informational report updates the activities of the CRR from its inception in January 2000 through April 2001. A history of events leading up to development of the CRR is briefly recounted below. Background In 1996, the CSA convened a major conference, "Clinical Research: Addressing the Future in a Changing Environment." Recommendations resulting from this conference were that a national summit of key stakeholders in clinical research 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.1 Following a mini-symposium on clinical research conducted at the 1996 meeting of the AMA’s Section on Medical Schools and a subsequent JAMA editorial,2 the Clinical Research Summit project, comprising more than 175 representatives from government and the private sector, was convened by the AMA, the Association of American Medical Colleges (AAMC), and Wake Forest University. Participants came from key government agencies, the pharmaceutical industry, major purchasers of health care, health plans and insurance companies, patient and family advocates, ethicists, the broad research community, and leaders of academic health centers. The summit was supported by 7 foundations, and the project took 18 months to complete. The Summit identified 9 core problems that confront the clinical research enterprise and developed a set of goals that were fully described in the Report of the Graylyn Consensus Development Conference, which was issued as a companion to the Summit’s final report, Clinical Research: A National Call to Action. One finding of the Graylyn Report was the lack of a "comprehensive, dynamic, clinical research agenda," with the Summit recommending that "a visible, credible, and broadly representative entity should be established to focus continuing national attention on the needs, priorities, and future progress of clinical research." Current AMA policy supports in general the findings of the Summit and specifically the establishment of the CRR (Policy H-460.918, AMA Policy Database). It was in response to this and to other recommendations of the Summit that the CRR was established. The information presented below is extracted to a large extent from a memorandum supplied by CRR staff; this memorandum served as the 2001Annual Report of the Roundtable.3 Mission By relying on a systematic, evidence-based exploration of the issues confronting clinical research, the CRR seeks to identify new approaches to address and resolve clinical research-related issues; clarify and expand areas of agreement and mutual understanding; and elevate the general understanding, visibility, and appreciation of the value of clinical research within the spectrum of affected communities, including the general public. Accomplishments Initial activities were devoted to developing the Roundtable infrastructure. The CRR recruited and selected staff and members and solicited funding. In addition to the AMA and AAMC, 12 other organizations, including federal agencies, pharmaceutical companies, and charitable foundations, pledged or provided financial support. These organizations and the IOM staff who support various aspects of the CRR are listed or described on the Web site. The CRR has been highly productive from the beginning. Each of its meetings has resulted in a journal publication that summarizes the meeting’s proceedings and the emergent themes, as well as a longer Web-based summary (including audio files of each of the presentations), which are valuable resources for those who are interested in clinical research issues. Meetings A detailed description of each meeting of the CRR, including mini-symposia, is available through the Web site, and brief synopses also have been published in the Journal of Investigative Medicine.4-6 During the first meeting in June 2000, the CRR held a mini-symposium entitled "The Clinical Investigator Workforce."4 The CRR also organized itself into 4 working groups that convene by conference call and some of which have been involved in organizing other mini-symposia for CRR meetings to identify agendas and plan future activities. The 4 working groups and their missions are:
An electronic discussion forum was established to facilitate communication between Roundtable members, and a Power Point presentation describing the CRR’s mission and activities was created and distributed. The latter was given to the IOM’s Board on Health Sciences Policy at its semi-annual board meeting in December 2000. At its second meeting in September 2000, the CRR held another mini-symposium entitled "Public Confidence and Involvement in Clinical Research."5 The Web site posting includes multiple links to participants’ biographical information, slides, audio of presentations, and links to the sponsoring organizations’ Web sites. In December 2000, the third meeting featured a mini-symposium on "Exploring the Map of Clinical Research for the Coming Decade." At this meeting, the CRR began to discuss and explore the concept of clinical research as a national enterprise. Exploring this concept further (ie, what the specific components are and how they might work together for mutual benefit) provides a potentially unifying direction for the CRR. Considering what clinical research should look like as a national enterprise, and identifying the primary obstacles and opportunities that face clinical research in the 21st century will help the CRR define the primary areas that need attention. Each of the 4 working groups is working independently on these objectives. The CRR will then determine which issues it will address in the coming years. During this meeting, chairs were selected to run the working groups, and membership on the working groups was reorganized so that each CRR member was assigned to only one group. In preparation for the March 2001 meeting, the working groups communicated via e-mail and conference call to clarify their focus and discuss plans. CRR staff assisted by filling in matrices for each group identifying opportunities and obstacles as well as ideas for the group to pursue. However, the March meeting was cancelled because of inclement weather and its agenda rescheduled for June 7-8, 2001. Dissemination and Outreach Activities One of the CRR’s major goals is to reach out to a larger audience. The CRR has taken a number of steps to accomplish this goal, including creating a Dissemination and Outreach group; surveying the membership to identify mechanisms for outreach; writing an action plan that outlines the steps the CRR can take to reach a larger audience; and creating a list of individuals who have expressed an interest in the CRR’s activities (called Friends of the Roundtable [FORT]). The CRR is using this e-mail list to announce public events and provide updates on its activities. It is in the process of creating an electronic means for individuals to join this list via the Web site and has identified a number of e-mail listservs that can be used to publicize the CRR Web site and distribute general announcements. Additionally, a publicity packet with information about the CRR and its publications is available, and staff and CRR members continue to attend conferences related to clinical research to learn more about what other groups are doing in this area. Staffing and Leadership Changes As the CRR moved into its second year of operation, the IOM announced the appointment of Queta Bond as co-chair to the Roundtable and Andrea Kalfoglou, PhD, joined the CRR staff as a program officer. In early February 2001, Douglas Boenning, MD, the senior staff officer, announced he was returning to full-time clinical practice and research. Alex Ommaya, ScD, was appointed to succeed Doctor Boenning, effective June 2001. Andrew Pope, PhD, Health Sciences Policy Board Director, is currently serving as the interim CRR Director. Future Activities Staff have created an action plan for the CRR and drafted a document called The National Clinical Research Enterprise, which lays out the current structure, identifies trends, and describes a vision of the "enterprise" in the future. The CRR is now focused on evaluating and developing clinical research as a national enterprise and is attempting to bring together all of the disparate components of clinical research. In so doing, the CRR continues to identify stakeholders and define their roles in this national enterprise. Conclusion The AMA in general, and the CSA in particular, have actively supported measures to enhance the conduct of clinical research in this country and to translate findings into clinical practice. The CRR has now entered its second year of operation and has begun to define an ambitious agenda around the concept of a "National Clinical Research Enterprise." The AMA is pledged to support the CRR for the inaugural 3-year period. The CSA will continue to monitor activities of the Roundtable and will provide periodic reports to the HOD and, as appropriate post relevant materials on the CSA Web site. RECOMMENDATIONS Because this is an information report, there are no Recommendations. References
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