Tradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs

The article discusses clinical trial optimization problems in the context of mid- to late-stage drug development. Using the Clinical Scenario Evaluation approach, main objectives of clinical trial optimization are formulated, including selection of clinically relevant optimization criteria, identifi...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2016-01, Vol.26 (1), p.120-140
Main Authors: Dmitrienko, Alex, Paux, Gautier, Pulkstenis, Erik, Zhang, Jianliang
Format: Article
Language:English
Subjects:
Adaptive designs
Assessments
clinical scenario evaluation
clinical trial optimization
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - statistics & numerical data
Criteria
Data Interpretation, Statistical
Decision making
Design analysis
Design optimization
Goals
Humans
Medical research
Multiple objective
multiple testing
Optimization
Research Design - statistics & numerical data
Sample Size
Sensitivity analysis
Statistics
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Summary:The article discusses clinical trial optimization problems in the context of mid- to late-stage drug development. Using the Clinical Scenario Evaluation approach, main objectives of clinical trial optimization are formulated, including selection of clinically relevant optimization criteria, identification of sets of optimal and nearly optimal values of the parameters of interest, and sensitivity assessments. The paper focuses on a class of optimization criteria arising in clinical trials with several competing goals, termed tradeoff-based optimization criteria, and discusses key considerations in constructing and applying tradeoff-based criteria. The clinical trial optimization framework considered in the paper is illustrated using two case studies based on a clinical trial with multiple objectives and a two-stage clinical trial which utilizes adaptive decision rules.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543406.2015.1092032