ing, patient and practitioner engagement, institutional resources, and the coordination and organization of clinical trial resources.

GAPS AND CHALLENGES IN THE CURRENT CLINICAL TRIALS INFRASTRUCTURE2

A key objective of health care reform in the United States is to encourage use of the most effective therapies and implementation strategies. This will require multiple types of clinical trials in many different settings.
—Paul Eisenberg, Amgen Inc.; Petra Kaufmann, National Institute of Neurological Disorders and Stroke (NINDS); Ellen Sigal, Friends of Cancer Research; and Janet Woodcock, Center for Drug Evaluation and Research, FDA

Clinical trials in the United States have become too expensive, difficult to enroll, inefficient to implement, and ineffective to support the development of new medical products, or the clinical effectiveness of these products, under modern scientific standards of evidence. This critique is expressed in the Discussion Paper prepared by Paul Eisenberg, Amgen Inc.; Petra Kaufmann, Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), NIH; Ellen Sigal, Chair and Founder, Friends of Cancer Research; and Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA. (See “Developing a Clinical Trials Infrastructure” in Appendix G). Ultimately, the purpose of CTE transformation is to facilitate development of more efficient and effective drugs and treatments, partly through continuous improvement of health care. A broad-based, sustainable infrastructure could support multiple types of clinical trials in different settings. Box 5-1 shows some of the elements of the clinical trials infrastructure that could be transformed.

A leading shortcoming of today’s CTE is low participation rates by patients and the public. To increase participation, the paper suggests the creation of clinical trial networks that are one of the following: disease-specific; created through CTSAs for a constellation of diseases or oriented around a specific subpopulation (e.g., children); or a “hub-and-spoke” arrangement between AHSSs and community health care providers. The success of CF advocates illustrates the power of a network to initiate and

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2 This section is based on the presentations and Discussion Paper by Paul Eisenberg, Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.; Petra Kaufmann, Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), NIH; Ellen Sigal, Chair and Founder, Friends of Cancer Research (unable to attend workshop); and Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA. (See Appendix G for the Discussion Paper “Developing a Clinical Trials Infrastructure.”)



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