Fighting against age discrimination in clinical trials.

Abstract:

:At the American Geriatrics Society 2008 Annual Meeting, representatives of two geriatric societies, the European Union Geriatric Medicine Societies and the American Geriatrics Society, and two regulatory agencies, the U.S. Food and Drug Administration and the European Medicine Agency, conducted a roundtable discussion aimed at reviewing the participation of older people in clinical trials. This article summarizes the important issues discussed at the meeting. Historically, regulatory agencies started to promote the inclusion of older participants in clinical trials in the late 1980s. The identification of the causes of delay in including older participants in clinical trials, as well as of the ongoing bias against including older participants with multiple comorbidities, is important to help geriatricians fight against age discrimination in clinical trials. To overcome this problem, geriatrics societies and regulatory agencies must work together to propose new definitions, study designs, and technologies aimed at improving the evaluation of drugs in older people with multiple comorbidities and polypharmacy.

journal_name

J Am Geriatr Soc

authors

Cherubini A,Del Signore S,Ouslander J,Semla T,Michel JP

doi

10.1111/j.1532-5415.2010.03032.x

subject

Has Abstract

pub_date

2010-09-01 00:00:00

pages

1791-6

issue

9

eissn

0002-8614

issn

1532-5415

journal_volume

58

pub_type

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