Informative noncompliance in endpoint trials

Current Controlled Trials in Cardiovascular Medicine
Steven M SnapinnBoris Iglewicz

Abstract

Noncompliance with study medications is an important issue in the design of endpoint clinical trials. Including noncompliant patient data in an intention-to-treat analysis could seriously decrease study power. Standard methods for calculating sample size account for noncompliance, but all assume that noncompliance is noninformative, i.e., that the risk of discontinuation is independent of the risk of experiencing a study endpoint. Using data from several published clinical trials (OPTIMAAL, LIFE, RENAAL, SOLVD-Prevention and SOLVD-Treatment), we demonstrate that this assumption is often untrue, and we discuss the effect of informative noncompliance on power and sample size.

References

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Citations

Oct 25, 2006·Clinical Trials : Journal of the Society for Clinical Trials·Bingbing Li, Patricia Grambsch
Sep 1, 2017·Journal of Biopharmaceutical Statistics·Richard F Potthoff
Oct 5, 2018·JAMA : the Journal of the American Medical Association·Sherman Gu

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Software Mentioned

OPTIMAAL

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