Highlights of Session on the Role of Other Stakeholders in the Clinical Research Enterprise

What can voluntary health associations, academic institutions, research or ganizations, and the medical device industry contribute to the Clinical Re search Enterprise?

  • Voluntary health associations such as the American Cancer Society and the American Diabetes Association contribute to the Clinical Research Enterprise by participating in and funding clinical research; recruiting patients for trials; advocating for funding and for high-quality patient care; translating research into clinical practice; educating professionals, patients, and the public; and in assisting in the creation of clinical guidelines.

  • The medical device industry produces innovative products that contribute to the armamentarium of health care treatments. Leaders of the medical technology community share the common goal of contributing to public policy solutions to issues of concern in that community.

  • The Agency for Healthcare Research and Quality supports and conducts research that will improve health outcomes, quality of care, and cost and utilization of health care services. Translating research into practice is a main priority. An important role is that of brokers of collaborations and partnerships—both public and private.

What do these organizations need from the Clinical Research Enterprise to better promote health and health care?

  • The results of basic research through the Clinical Research Enterprise have been critical to progress in the prevention and treatment of diseases such as cancer and diabetes, but more research is needed.

  • The business case needs to be made that disease prevention is important; i.e., the cost benefit of preventive methods needs to be proven.

  • Consumers need to be given incentives to take better care of their health.

  • Barriers to the dissemination of research and clinical information need to be eliminated. Protection of privacy is also essential, particularly in light of rapid progress in genome research.

  • An infrastructure must be put in place for a new type of research—evaluative research—that is aligned with overall priorities for health care.

  • Interventions for coordinating patient care, improving quality, and eliminating waste and medical errors should be evaluated. All stakeholders have a role in this endeavor, which will involve creating systems and changing the existing health care culture.

  • Research is needed on how partnerships among providers, purchasers, and payers can create quality improvement in health care delivery.

  • Selecting clinical research priorities poses an enormous challenge but must be attempted. Questions include: Who should determine these priorities? What aspects of selected diseases warrant the most attention? What type of clinical research needs to be conducted?

  • A “Catch-22” in funding of research by industry needs to be resolved. Research findings may be discredited when industry invests in clinical trials to obtain evidence for payers or the FDA; yet who else will fund the research and provide the information? More guidance is needed as to how to evaluate research findings and what standards must be met.

  • The Clinical Research Enterprise needs to promote a paradigm shift that would transform the current individual-driven research and professional culture into a team effort.

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