The need for randomization in the study of intended effects

Stat Med. 1983 Apr-Jun;2(2):267-71. doi: 10.1002/sim.4780020222.


The need for randomization as a means of controlling confounders is accentuated in the study of intended effects (efficacy) as compared with unintended ones (toxicity). The basic reason is that the indication for intervention is inherently a confounder in the study of efficacy but not of toxicity, whereas contraindications represent only a minor confounder even in toxicity research. Moreover, control of the indication in non-experimental terms is commonly infeasible owing to the complexity and subtlety of the indication.

Publication types

  • Comparative Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials as Topic*
  • Humans
  • Iatrogenic Disease / epidemiology
  • Statistics as Topic*
  • Therapeutics*