TY - JOUR
T1 - Fighting against age discrimination in clinical trials
AU - Cherubini, Antonio
AU - Signore, Susanna Del
AU - Ouslander, Joe
AU - Semla, Todd
AU - Michel, Jean Pierre
PY - 2010
Y1 - 2010
N2 - 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.
AB - 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.
KW - clinical trial
KW - exclusion
KW - geriatric medicine
KW - older participant
KW - regulatory agency
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U2 - 10.1111/j.1532-5415.2010.03032.x
DO - 10.1111/j.1532-5415.2010.03032.x
M3 - Article
C2 - 20863340
AN - SCOPUS:77956325385
VL - 58
SP - 1791
EP - 1796
JO - Journal of the American Geriatrics Society
JF - Journal of the American Geriatrics Society
SN - 0002-8614
IS - 9
ER -