BOX 6-1
Key Themes of Clinical Trials Enterprise Transformation Suggested at the Workshop

This box provides an integrated summary of presentations by Alastair Wood, Professor of Medicine and Pharmacology, Weill Cornell Medical College, and Symphony Capital LLC; Sherine Gabriel, William J. and Charles H. Mayo Professor of Medicine and Epidemiology, Mayo Medical School; Arthur Rubenstein, Professor of Medicine, Division of Endocrinology, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania; and Clyde Yancy, Chief of Cardiology, Northwestern University Feinberg School of Medicine, and Associate Director, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital. These speakers were asked to summarize and discuss key themes arising from their respective sessions of the workshop.

Convergence of Clinical Research and Clinical Practice

•      Incorporate clinical research and clinical trials into continuous quality improvement activities of the health care system. Most clinical decisions apparently are not yet based on scientific evidence; broad engagement of, and partnership with, community health care providers and patients could provide excellent opportunities to generate valid, reliable, and relevant evidence and incorporate it into medical practice.

•      Focus clinical trials on answering important health questions likely to draw greater interest and support from patients, the public, practitioners, and payers.

•      Design less bureaucratic platforms for studies, using EHRs maintained in routine care and novel ways of randomizing patients. Different treatments and populations will give rise to the need for different approaches.

•      Expand research networks and collaborate with professional societies in order to centralize processes and induce more physicians to participate in research. Strive to reduce the large footprint on clinical practice that research imposes; research will become part of routine practice only if it is not overly cumbersome.

Workforce and Career Development

•      Ensure that those who develop clinical trials examine trial proposals from the perspective of a scientist, as well as from the patient perspective in order to understand what an appropriate and meaningful clinical trial would look like for patients and society.

•      Greater diversity in the research workforce would help respond to changing U.S. demographics.

•      Secondary education may be an effective venue for educating the public about scientific evidence and beginning to attract young people to careers in science.

•      More attention to research in medical schools could improve practitioners’ attitudes toward research and attract young physicians to research careers. Innovations in education and training to prepare researchers to collaborate with clinicians could lead to better trials.

•      Build education programs—prelicensure, graduate, and lifelong learning—on needs assessments that take into account knowledge gaps, research methodology, interpretation of results, implementation of findings, design thinking, team leadership skills, and business skills.

•      Place a higher value on clinical trials research in tenure decisions could enhance CTE career ladders.

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