[Clinical trials in very elderly people: the point of view of geriatricians].
BACKGROUND
Very elderly subjects (aged > or =80 years) and polypathological elderly subjects experience frequent and serious adverse drug effects. They are nevertheless still excluded from clinical research.


METHODS
We questioned geriatricians through a questionnaire about the usefulness and feasibility of randomised controlled trials (RCTs) in this population.


RESULTS
Forty-eight percent of geriatricians questioned did participate in RCTs, but 96.8% considered that RCTs including very elderly subjects were scientifically necessary. Among geriatricians who never participated in RCTs, 36% were never contacted regarding participation in such clinical research. The most important difficulties in developing RCTs in very elderly subjects were methodological difficulties (narrow eligibility criteria incompatible with patient heterogeneity) and those associated with patient consent. For 38.2% of the geriatricians, the fact that pharmaceutical companies are under no obligation to promote RCTs in very elderly subjects represents a major obstacle in the development of such RCTs.


CONCLUSIONS
The development of RCTs involving very elderly subjects depends first on a political choice, together with an adapted regulatory framework.
Le Quintrec
Jean-Laurent
JL
Service de Gérontologie I, Hôpital Ste-P6rine AP-HP, Paris, France. muriel.palomares@spr.ap-hop-paris.fr
Piette
François
F
Hervé
Christian
C
D000368:Aged / Q000502:physiology*; D000369:Aged, 80 and over / Q000502:physiology*; D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic; D003625:Data Collection; D064420:Drug-Related Side Effects and Adverse Reactions; D005853:Geriatrics / Q000639:trends*; D006801:Humans; D016032:Randomized Controlled Trials as Topic