Fighting against age discrimination in clinical trials.
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.
Cherubini
Antonio
A
Institute of Gerontology and Geriatrics, Perugia University Medical School, Policlinico Santa Maria della Misericordia, Perugia, Italy. cherubin_9@yahoo.com
Del Signore
Susanna
S
Ouslander
Joe
J
Semla
Todd
T
Michel
Jean-Pierre
JP
D000375:Aging / Q000523:psychology*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D004992:Ethics, Medical; D005853:Geriatrics / Q000331:legislation & jurisprudence*; D006801:Humans; D018579:Patient Selection; D011287:Prejudice; D012955:Societies, Medical