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Viewpoint |

Engaging Patients Across the Spectrum of Medical Product Development View From the US Food and Drug Administration

Nina L. Hunter, PhD1; Kathryn M. O’Callaghan, BSE1; Robert M. Califf, MD2
[+] Author Affiliations
1Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland
2Office of Medical Products and Tobacco, US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2015;314(23):2499-2500. doi:10.1001/jama.2015.15818.
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This Viewpoint discusses the conceptual framework of the Precision Medicine Initiative that could lead to improved health by more effectively matching medical products to the needs and preferences of patients and care partners.

The complex tasks of developing, evaluating, and determining the appropriate use of medical technologies occur in an evolving ecosystem of diverse stakeholders. However, as new medical therapies and diagnostics are designed and tested, the preferences and views of the patients and care partners who are most directly affected by these treatments are all too often overlooked. Individual patients often experience different effects of diseases and may have unique preferences about treatments or diagnostic procedures that differ from those of other patients or of their physicians or other health care practitioners; they may also have differing views about what kinds and degrees of risk are tolerable. As patients weigh the balance of benefits and risks, their decisions are informed by their experiences, backgrounds, and personal circumstances. In addition, patients are no longer passive recipients of care; instead, they are empowered consumers of medical products and partners in the process by which those products are developed. Patients increasingly act as advocates for new treatments, and many are fully engaged in making decisions about their care.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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