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Clinical Trial Optimization Using R
Clinical Trial Optimization Using R

Book Details

2.5 Case study 2.3: Tradeoff-based selection of optimal procedure parameters -- 2.5.1 Clinical trial -- 2.5.2 Optimal selection of the target parameter in Procedure H -- 2.5.3 Software implementation -- 2.5.4 Conclusions and extensions -- 3: Subgroup Analysis in Clinical Trials -- 3.1 Introduction -- 3.2 Clinical Scenario Evaluation in confirmatory subgroup analysis -- 3.2.1 Clinical Scenario Evaluation framework -- 3.2.2 Multiplicity adjustments -- 3.2.3 Decision-making framework -- 3.3 Case study 3.1: Optimal selection of a multiplicity adjustment -- 3.3.1 Clinical trial -- 3.3.2 Direct optimization based on disjunctive power -- 3.3.3 Direct optimization based on weighted power -- 3.3.4 Qualitative sensitivity assessment -- 3.3.5 Quantitative sensitivity assessment -- 3.3.6 Software implementation -- 3.3.7 Conclusions and extensions -- 3.4 Case study 3.2: Optimal selection of decision rules to support two potential claims -- 3.4.1 Clinical trial -- 3.4.2 Influence condition -- 3.4.3 Optimal selection of the influence threshold -- 3.4.4 Software implementation -- 3.4.5 Conclusions and extensions -- 3.5 Case study 3.3: Optimal selection of decision rules to support three potential claims -- 3.5.1 Clinical trial -- 3.5.2 Interaction condition -- 3.5.3 Optimal selection of the influence and interaction thresholds -- 3.5.4 Software implementation -- 3.5.5 Conclusions and extensions -- 4: Decision Making in Clinical Development -- 4.1 Introduction -- 4.2 Clinical Scenario Evaluation in Go/No-Go decision making and determination of probability of success -- 4.2.1 Clinical Scenario Evaluation approach -- 4.2.2 Go/No-Go decision criteria -- 4.2.3 Probability of success -- 4.2.4 Probability of success applications -- 4.3 Motivating example -- 4.3.1 Clinical trial -- 4.3.2 Software implementation
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  • Authors Alex Dmitrienko, Erik Pulkstenis
  • ISBN13 9781498735070
  • ISBN10 149873507X
  • Pages 319
  • Published 2026
  • Fecha de publicación 11/05/2026
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