Although RCTs, the primary focus of the Forum’s workshop series on clinical trials, will continue to play an important role in the development of new drugs and therapies, many believe the approach is not always feasible, ethical, or practical to answer the wide array of research questions facing the nation today. The scientific value of RCTs is well established, but the high cost and time commitment required for these studies, combined with the often limited applicability of results to patient populations that differ from those in the original study, can disassociate this type of research from the reality of medical practice. A primary theme of the workshop is the need to bridge the divide between clinical research and clinical practice— i.e., to effectively bring clinical research into the community. Doing so would involve partnerships among researchers, physicians, and patients and facilitate the development of studies focused on answering meaningful questions for clinical practice, which in turn could inform the development of new, targeted therapies for the changing health needs of the population.

Workshop participants discussed a broad range of research methods that would engage patients and clinicians and go beyond determinations of efficacy (i.e., can it work under ideal circumstances?) to evaluate clinical effectiveness (i.e., can it work in real world, clinical practice settings?). It was noted at the workshop that the full battery of clinical research methods will be necessary to improve our understanding of the questions that emerge through the lifecycle of a medical product. For instance, Figure 1 suggests a timeline of medical products research and the corresponding development of various types of evidence.

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FIGURE 1 Evidence development in the learning health system over the course of a medical product’s lifetime.
SOURCE: IOM, 2010b. Redesigning the Clinical Effectiveness Research Paradigm.



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