Workshop Summary

The goal of the workshop that is the topic of this summary report, The Role of Purchasers and Payers in the Clinical Research Enterprise, was to examine how purchasers and payers interact with the various components of the Clinical Research Enterprise and to understand their perspective on what the vision of the enterprise should be. Representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, researchers, research organizations, and the technology community) came together to explore the following questions: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? The workshop integrated the diverse views of the stakeholders and created a lively dialogue among the participants. Clinical research is defined broadly in this research, encompassing all patient oriented research, health services research, epidemiology, outcomes, and behavior research (see Appendix V). The language presented in this respect should not be viewed as an endorsement by the Clinical Research Roundtable or the Institute of Medicine of future action that is needed, but rather as an effort to synthesize the various perspectives presented.

The introductory presentation by the co-chairs of the workshop (Sean Tunis, M.D., of the Centers of Medicare and Medicaid Services, and Allan Korn, M.D., of the Blue Cross and Blue Shield Association) set the tone by emphasizing how quality of care depends on the quality of information underlying health care decisions. The speakers then postulated that the Clinical Research Enterprise



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Workshop Summary The goal of the workshop that is the topic of this summary report, The Role of Purchasers and Payers in the Clinical Research Enterprise, was to examine how purchasers and payers interact with the various components of the Clinical Research Enterprise and to understand their perspective on what the vision of the enterprise should be. Representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, researchers, research organizations, and the technology community) came together to explore the following questions: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? The workshop integrated the diverse views of the stakeholders and created a lively dialogue among the participants. Clinical research is defined broadly in this research, encompassing all patient oriented research, health services research, epidemiology, outcomes, and behavior research (see Appendix V). The language presented in this respect should not be viewed as an endorsement by the Clinical Research Roundtable or the Institute of Medicine of future action that is needed, but rather as an effort to synthesize the various perspectives presented. The introductory presentation by the co-chairs of the workshop (Sean Tunis, M.D., of the Centers of Medicare and Medicaid Services, and Allan Korn, M.D., of the Blue Cross and Blue Shield Association) set the tone by emphasizing how quality of care depends on the quality of information underlying health care decisions. The speakers then postulated that the Clinical Research Enterprise

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currently does not produce an adequate volume or quality of information to support policy decision making at various levels—from employers, physician groups, government health programs, and health plans, to the ultimate end users, the consumers. Against this background, speakers from purchaser, payer, and other stakeholder organizations laid out a mosaic of views. In the first session, The Role of Purchasers in the Clinical Research Enterprise, representatives of large employers and business organizations (General Motors Corporation, United Parcel Service, the National Business Coalition on Health, Verizon, the Washington Business Group on Health, Marriott International, and William M. Mercer Inc.) responded by describing what they need from the Clinical Research Enterprise. Speakers agreed that purchasers need the enterprise to provide them with knowledge of new technological innovations and treatments that have been proven effective through evidence from well-designed, well-executed, unbiased studies. They stated their need to understand why clinical practices vary widely and why agreed-upon practices are not uniformly performed, and they requested help in reducing this variation. They expressed their willingness to pay for quality in health care, but noted that they need to know what they will receive for their investment, either in the short-term or the long-term. Purchasers recognized a trend toward a consumer-driven health care system in this country, and they acknowledged the important contribution that they can make in preventive health by educating their members and encouraging healthy lifestyle behaviors. They expressed interest in contributing to a national fund that would be used to examine research questions of national significance that are not currently being addressed, but they reiterated that they would need to know what the return would be for their investment. Finally, they considered the possibility of joining with payers to compile and publish a list of top-priority clinical research projects. In the second session, The Role of Payers in the Clinical Research Enterprise, speakers from four health plans (Wellmark, HealthPartners, United Healthgroup, and Aetna U.S. Healthcare) and a representative from the American Association of Health Plans revisited many themes brought out in the purchaser session. They emphasized their need to understand what is effective and what is not in the care of patients, the prevention of disease, and the promotion of health. They discussed the need for full disclosure of information regarding research funding to the public, potential research participants, and other stakeholders. They acknowledged the need to know how to provide safer care and eliminate errors to keep members free from harm. They requested guidance on how to transform the culture of medical practice from a profession-centered, individual activity into a patient-centered, team effort. They wished for more insight into population-based community methods of improving individual and community health, and they asked for help in eliminating barriers to the delivery of interventions for behavioral change. Payers acknowledged that the Clinical Research Enterprise provides innova

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tions that improve care, prevent illness, and promote health. They recognized that the enterprise questions existing practice and helps eliminate ineffective and even harmful practices. They expressed their willingness to encourage dissemination of medical technologies of proven safety and effectively and to support the implementation of evidence-based guidelines and consensus statements in clinical practice. Further, they emphasized the important role that they play in imparting health information to their members through health education programs and encouraging healthy behaviors. The third session, The Role of Other Stakeholders in the Clinical Research Enterprise, brought together representatives from voluntary health organizations (the American Cancer Society and the American Diabetes Association), researchers, the medical technology community (the Medical Technology Leadership Forum), and the Agency for Healthcare Research and Quality to discuss their contributions to the Clinical Research Enterprise and what they need from it to better promote health and health care. Speakers from the American Cancer Society and the American Diabetes Association described the contributions of their organizations to the Clinical Research Enterprise, which included participating in and funding clinical research, translating research into clinical practice, aiding in the creation of clinical guidelines, and advocating for funding and high-quality care for every patient. They acknowledged their special role in educating professionals, patients, and the public in health care and prevention. Representatives of the academic research institutions discussed the deficiencies in the current research structure and called for a new type of research, evaluative research, that requires setting priorities for health care and working cooperatively to conduct research that is closely aligned with those priorities. They affirmed that researchers can assist the progress of the Clinical Research Enterprise by working with purchasers and payers to evaluate the impact of collaborative programs and interventions. A speaker from the medical technology community emphasized the unique characteristics of the medical device industry, such as short product life cycles and high clinical trial costs per unit, and called for assistance from the Clinical Research Enterprise in evaluating new technology. A representative of the Agency for Healthcare Research and Quality described its mission, which is to support and conduct research that will improve health outcomes, quality of care, and cost and utilization of health care services. Participants in this session also identified the need for a paradigm shift away from the current individual investigator-driven research toward research based on wide collaboration and teamwork. The goal of the final session of the workshop, Opportunities and Challenges in the Clinical Research Enterprise, was to explore opportunities for new approaches to research and patient care and examine challenges associated with research funding. These topics engendered discussion by participants representing a wide range of stakeholder interests. A representative from Merck and Company presented an example of outcomes research, which examines the conse

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quences of medical treatment in terms of what is important to those being treated and leads to disease management. During the ensuing discussion an initiative called integrated patient-centered care, which goes beyond disease management by considering the whole person, was described. A lively discussion centered around the issue of conflict of interest in industry-funded research. In conclusion, prevailing themes throughout the workshop were the need for research to determine what does and does not work in treatment, diagnosis, and prevention; the need to translate basic science research into clinical recommendations, and clinical guidelines into consistently practiced best evidence-based care; and the need to transform the professional health care culture into a team effort. Participants recognized the trend toward a consumer-driven health care system, and they affirmed their commitment to the public good. They came away from the workshop with a clearer understanding of each others’ views and a commitment to search for unique solutions to the nation’s health care questions and to work together to apply them.