Research Article

The case for recording events in clinical trials.

Br Med J 1977; 2 doi: https://doi.org/10.1136/bmj.2.6101.1523 (Published 10 December 1977) Cite this as: Br Med J 1977;2:1523
  1. D C Skegg,
  2. R Doll

    Abstract

    The value of clinical trials in detecting unwanted effects of new medicines would be enhanced if doctors recorded all adverse events experienced by patients and not just those regarded as adverse reactions to drugs. All events should be reported to the centre co-ordinating the trial and analysed in treated patients and controls. This method might have revealed the ocular toxicity of practolol before the drug was marketed in 1970.