Apport des essais pré-AMM à la connaissance du risque iatrogène chez la personne âgée

Abstract

Premarketing trials contribute poorly to predicting drug-related iatrogenic effects in elderly patients. Since their main goal is the demonstration of drug efficacy, these trials are characterised by a simplistic design, they include a limited number of young participants (volunteers only), are of a short duration, and follow a strict protocol. Results of studies in young people cannot be extrapolated to elderly people. Although licensing authorities recommend the recruitment of a meaningful number of elderly people in clinical trials (with an age distribution comparable to that expected when the drug is in routine use), even in trials that are not devoted to geriatric illnesses, elderly people remain substantially under-represented in most instances for methodological reasons (to avoid increased variance introduced by a heterogenous population), safety reasons (at this stage of drug development, it could be deleterious to include patients with comorbid conditions and unfair with regard to the brand image of the products), and ethical reasons (the decision to participate could not be taken by the elderly people alone). Exclusion of elderly participants, who are particularly exposed to drug-related iatrogenic effects, influences the generalisability of study findings. The recruitment of elderly participants, a vulnerable population, is necessary to allow valid conclusions regarding elderly people, recommendations on the appropriate dosage adjustment for elderly individuals, the avoidance of prescribing decisions based on inadequate information (with respect to a more informative summary of the characteristics of the products), and the maximum benefit for elderly people from research.