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U.S. Department of Health and Human Services

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Transplantation 2013 Apr 15;95(7):916-8

FDA Perspective: Enrolment of Elderly Transplant Recipients in Clinical Trials.

Meyer JM, Archdeacon P, Albrecht R


Since 1989, the U.S. Food and Drug Administration (FDA) has encouraged the study of new drug and therapeutic products in elderly patients. However, despite the aging population in the United States, elderly patients continue to be underrepresented in clinical trials across a variety of therapeutic areas, including transplantation. The currently available tools for the FDA to encourage and require the evaluation and reporting of safety and efficacy information in elderly patients are summarized. Clinicians, sponsors, and investigators are encouraged to work with the FDA to expand the enrolment of elderly patients in clinical trials of transplantation.

Category: Journal Article
PubMed ID: #23380880 DOI: 10.1097/TP.0b013e31828279d9
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2013-02-07 Entry Last Modified: 2013-07-09