Effects on Overviews of Early Stopping Rules for Clinical Trials

Stat Med. Apr-May 1987;6(3):361-9. doi: 10.1002/sim.4780060329.


Use of inappropriate stopping rules for clinical trials results in an excess of false positive conclusions when no true survival differences exist. Overviews of such trials, however, consist mainly of trials which were not stopped early, plus a few of reduced sample size which were. Simulations confirm that the level of such an overview is minimally elevated. Additional follow-up for survival further corrects the level. In fact, for individual trials conducted according to inappropriate rules, late tests have nearly correct level. On the other hand, publication bias (differential reporting of positive results) can substantially increase the level of an overview if only published studies are included.

MeSH terms

  • Clinical Trials as Topic / standards*
  • Data Collection / methods
  • Follow-Up Studies
  • Humans
  • Neoplasms / mortality
  • Neoplasms / therapy
  • Research Design / standards*