FDA perspective: enrolment of elderly transplant recipients in clinical trials.

Abstract:

: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.

journal_name

Transplantation

journal_title

Transplantation

authors

Meyer JM,Archdeacon P,Albrecht R

doi

10.1097/TP.0b013e31828279d9

subject

Has Abstract

pub_date

2013-04-15 00:00:00

pages

916-8

issue

7

eissn

0041-1337

issn

1534-6080

journal_volume

95

pub_type

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