Highlights of Session on Opportunities and Challenges in the Clinical Research Enterprise

What are the opportunities for new approaches to research and patient care?

  • Having physicians practice evidence-based medicine, setting care objectives, collecting data, and being accountable involves starting with outcomes research and moving to disease management.

  • Outcomes research examines the consequences of medical treatment in terms of what is important to patients and their families—not only dichotomous variables such as whether people live or die, but also humanistic outcomes such as quality of life, functional status, and patient satisfaction. Such research provides a key to disease management.

  • Disease management is a process that assists payers and providers in improving clinical outcomes and quality of life, and in managing health care costs using the principles of quality management.

  • The total cost of health care, not just individual cost centers, must be managed. The Department of Veterans Affairs provides a model for such management.

  • A new paradigm in the relationship between physician and patient is a dynamic relationship in which information is shared and the physician can present choices to the patient, who can then make informed decisions.

  • Integrated patient-centered care goes beyond disease management because it takes into account the patient with multiple chronic diseases and looks at the whole person. Information is shared across providers.

What are the challenges facing the Clinical Research Enterprise?

  • Methods must be developed to resolve long-standing issues that have presented barriers to evidence-based practice. These methods include changing medical school curricula, building systems and infrastructure, and orienting providers, purchasers, payers, and patients in this direction.

  • The issue of how to provide payers with information that they can use to inform their decisions must be settled. Currently, investigator initiated research sponsored by the government and product-driven research supported by industry may not adequately address the information needs of the payers. Conflict-of-interest issues in funding need to be addressed.

  • The paradigm shift from individual, investigator-driven research to research conducted by large coalitions of multidisciplinary groups—which is being driven by demand from public, the genome project, and all stakeholders in the Clinical Research Enterprise—will require a large infrastructure and an enormous funding effort.

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