Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database.

Rikje RuiterJacobus BurggraafRobert Rissmann

Published in: British journal of clinical pharmacology (2019)

The under-representation of elderly in clinical trials thereby challenging the external validity of benefit/risk assessments of launched drugs was confirmed. Priority should be given to a study population that is representative for the target population.

Keyphrases

clinical trial
drug administration
middle aged
community dwelling
phase ii
cross sectional
open label
emergency department
risk assessment
neural network
climate change