Futility interim monitoring with control of type I and II error probabilities using the interim Z-value or confidence limit

Clinical Trials : Journal of the Society for Clinical Trials
John M Lachin

Abstract

It is highly desirable to terminate a clinical trial early if the emerging data suggests that the experimental treatment is ineffective, or substantially less effective than the level the study was designed to detect. Many studies have used a conditional power calculation as the basis for termination for futility. However, in order to compute conditional power one must posit an assumption about the distribution of the future data yet to be observed, such as that the original design assumptions will apply, or that the future data will have the same treatment effect as that estimated from the current 'trend' in the data. Each such assumption will yield a different conditional power value. The assessment of futility is described in terms of the observed quantities alone, specifically the interim Z-value or the interim confidence limit on the magnitude of the treatment effect, such that specified type I and II error probabilities are achieved. No assumption is required regarding the distribution of the future data yet to be observed. Lachin [1] presents a review of futility stopping based on assessment of conditional power and evaluates the statistical properties of a futility stopping rule. These methods are adapted to futility st...Continue Reading

References

Apr 30, 1993·Statistics in Medicine·K K Lan, D M Zucker
Oct 21, 2000·Controlled Clinical Trials·G W Comstock
Sep 1, 2005·Statistics in Medicine·John M Lachin
Dec 1, 2005·Clinical Trials : Journal of the Society for Clinical Trials·John M Lachin

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Citations

Feb 23, 2012·Clinical Trials : Journal of the Society for Clinical Trials·Haesook Teresa Kim, Robert Gray
Jan 1, 2016·Journal of the American College of Cardiology·Stuart J PocockGregg W Stone
Jun 17, 2014·Journal of Biopharmaceutical Statistics·Paul GalloVivian H Shih
Aug 6, 2002·Controlled Clinical Trials·Boris Freidlin, Edward L Korn
Apr 29, 2010·Clinical Trials : Journal of the Society for Clinical Trials·Boris FreidlinRobert Gray
Sep 3, 2016·Statistical Methods in Medical Research·Adriani NikolakopoulouGeorgia Salanti
Jul 19, 2015·Statistical Methods in Medical Research·Han Zhu, Qingzhao Yu
Jan 30, 2019·Biometrical Journal. Biometrische Zeitschrift·Julia NiewczasFranz König
Jun 28, 2020·Journal of Clinical Periodontology·Shang-Jie TsaiYu-Kang Tu

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