Fighting against age discrimination in clinical trials

Original article by: A Cherubini, S Del Signore, J Ouslander, T Semla, J-P Michel

Reference: Journal of the American Geriatrics Society Sep 2010;58(9):1791-1796

Source: Journal of the American Geriatrics Society

Keywords: Aged; Bias; Clinical Trials; Drug Therapy-Combination; European Medicines Evaluation Agency; Food and Drug Administration; Viewpoint;

Date published: 06/09/2010 16:45

Summary
by: Pharm-line

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 US 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 summarises 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.

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