Group-Sequential Clinical Trials with Multiple Co-Objectives
Springer, Jun 1, 2016 - Mathematics - 113 pages
This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting effect on power and type I error rate. The book also describes group sequential strategies for three-arm clinical trials to demonstrate the non-inferiority of experimental intervention to actively control and to assess the assay sensitivity to placebo control.
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2 Interim Evaluation of Efficacy in Clinical Trials with Two Coprimary Endpoints
3 Sample Size Recalculation in Clinical Trials with Two Coprimary Endpoints
4 Interim Evaluation of Efficacy or Futility in Clinical Trials with Two Coprimary Endpoints
5 Interim Evaluation of Efficacy in Clinical Trials with Two Primary Endpoints
6 GroupSequential ThreeArm Noninferiority Clinical Trials
7 Future Developments
Appendix ACalculation of Power and ConditionalPower in GroupSequential Clinical Trialswith Two Coprimary Endpoints
Appendix BEfficacy and Futility Critical Boundariesand Sample Size Calculationin GroupSequential Clinical Trialswith Two Coprimary Endpoints
Appendix DASN Calculations in ThreeArmGroupSequential Clinical Trials
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1.0 Correlation ¼ qC ¼ Accessed 25 Nov active control adaptive designs Alzheimer’s disease Asakura assay sensitivity based on DF-A Biometrics Biometrika cNIl critical boundary combinations decision-making frameworks DeMets detect the joint efficacy and futility endpoint is tested endpoints OF-OF endpoints PC-PC equally sized groups equally spaced increments error rate European Medicines Agency evaluate futility assessments futility critical boundaries group equally sized group-sequential clinical trial group-sequential designs Hamasaki hypothesis testing increments of information interim analysis intervention group equally irritable bowel syndrome joint effect Lan–DeMets error-spending method lth analysis MSS and ASN multiple co-primary endpoints multiple endpoints non-inferiority null hypothesis number of planned one-sided test outcomes PC for EP2 PC-OF placebo planned analyses power at 2.5 Power2 prespecified primary endpoints q ¼ reject H0 sample size recalculation sequential significance level Sozu standardized mean differences stopping rule Sugimoto test intervention test statistic trials with multiple Type I error weighted Bonferroni procedure