The effect of poor compliance and treatment side effects on sample size requirements in randomized clinical trials

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

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
Volume4
Issue number2
DOIs
StatePublished - Jan 1 1994

Keywords

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

Fingerprint

Dive into the research topics of 'The effect of poor compliance and treatment side effects on sample size requirements in randomized clinical trials'. Together they form a unique fingerprint.

Cite this