Assessing general side effects in clinical trials: reference data from the general population

Abstract

We suggest that a structured, patient-based approach to assess general side effects could improve the detection of drug-induced side effects. The problem of clinical studies being underpowered to detect side effects could be reduced by using more reliable approaches. Our plea is for side effect ascertainment with sophisticated approaches for expected side effects, systematic screening for general side effects, and open question methods for spontaneous reports.