[Good clinical practices in therapeutic trials in geriatrics especially in Alzheimer type senile dementia].
The rules of "Good clinical practices" 1987 and the law of December 20, 1988 concerning biomedical research give guidelines that are difficult to apply in Geriatrics. Pragmatic solutions have to be proposed if we want to avoid delay in clinical research especially in degenerative diseases and in the evaluation of therapeutics in old age. We can focus the problems on the chapter "Responsibilities of the investigator": 1) His professional qualification whereas gerontology in not yet considered as a specialty; 2) Obtention of informed consent in general, especially written informed consent and leaflet informations given to patients; 3) Constitution of staff according to low motivation of nurses to research and low methodological knowledge; investigators' disponibility considering low density of nurses and physicians in geriatric units. Among specific points of "Good clinical practices" for home trials we need a careful selection of general practitioners interested in both geriatrics and therapeutic trials. Finally obtaining pharmacokinetic data in elderly needs probably a clear distinction between two ways: classical pharmacokinetic studies with samples of old healthy paid volunteers and pharmacokinetic study of a population in therapeutic trials.
Piette
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Service de Gérontologie, Hôpital Charles Foix, Ivry.
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D004341:Drug Evaluation / Q000379:methods*; D005602:France; D005853:Geriatrics; D006801:Humans; D007258:Informed Consent; D008503:Medical Staff