market evaluations in broad populations as well as approval studies, cross-disciplinary education and training, alignment of policy goals with funding, publication and career advancement opportunities, improved linkages with healthcare delivery systems).

The final workshop sessions were dedicated to discussion of how the research community might be organized, mobilized, and supported to effect broad changes needed. Common themes and follow-up opportunities for the Roundtable, noted throughout the discussion are also summarized here.1


The multifaceted, practice-oriented approach to clinical effectiveness research discussed at the workshop complements and blends with traditional trial-oriented clinical research and may be represented as a continuum in which evidence is continuously produced by a blend of experimental studies with patient assignment (clinical trials); modeling, statistical, and observational studies without patient assignment; and monitored clinical experience (see Figure 7-1).

The ratio of the various approaches will vary with the nature of the intervention, as does the weight given to the available studies. This enhanced flexibility and range of research resources is facilitated by the development of innovative study design and analytic tools, and by the growing potential of electronic health records to allow much broader structure access to the results of the clinical experience. The ability to draw on real-time clinical insights will naturally improve over time.

The research community will play a vital role in developing a clinical effectiveness research enterprise that provides timely, reliable information that can be used in clinical decision making. Discussions throughout the workshop not only highlighted current shortfalls in the quality, quantity, and efficiency of this current research, but also explored many opportunities to develop incentives for the changes needed and to support those changes once they have been implemented. As reviewed in previous chapters, many elements are being developed and used to ensure research can be used more effectively to make evidence-based decisions in a clinical setting. These elements include innovative tools, techniques, and strategies that improve the efficiency and reliability of study methodologies; vastly larger and clinically richer datasets; and advances in information technology that will connect researchers and information, thus enabling studies not possible before. In some respects the largest challenge is engaging the research community


This chapter is drawn from the panel discussion and concluding summary comments at the workshop made by Michael McGinnis and the submitted comments of participants during and following the meeting. They do not constitute consensus findings or recommendations of the Institute of Medicine or the National Academies.

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