8 Scopus citations


Treatment side effects and associated noncompliance have methodological implications vital to the testing of new drugs. In this paper, we quantify the impact of these factors on sample size requirements in clinical trials. In the Lipid Research Clinics Trial, side effects caused treatment group compliance (50.8%) to be lower than placebo compliance (67.3%). Cholesterol reduction among treatment noncompliers was 35.2% of the reduction among com-pliers. Had treatment group compliance been as high as placebo compliance, 41% fewer patients would have been required to achieve.

Original languageEnglish
Pages (from-to)223-232
Number of pages10
JournalJournal of Biopharmaceutical Statistics
Issue number2
StatePublished - Jan 1 1994


  • Lipid Research Clinics trial
  • Noncompliance
  • Randomized clinical trials
  • Sample size requirements
  • Treatment side effects


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