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Futility stopping in clinical trials, optimality and practical considerations
Yen Chang1, Tianhao Song1, Jane Monaco1
1Department of Biostatistics, The University of North Carolina, Chapel Hill, North Carolina, USA.
Journal of Biopharmaceutical Statistics
|September 14, 2020
Summary
Stopping clinical trials early for futility is efficient, especially in oncology. This review covers optimal timing and methods for futility stopping in various trial designs.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Oncology Research
Background:
- Futility stopping is a valuable strategy in clinical trial design.
- It is commonly implemented in single-arm oncology trials and various two-arm trial designs.
- Efficient trial management necessitates understanding and applying futility stopping rules.
Purpose of the Study:
- To review existing futility stopping rules for clinical trials.
- To provide recommendations for optimizing the timing of futility assessments in two-stage trials.
- To discuss considerations for futility stopping in trials with outcome variability and crossover designs.
Main Methods:
- Review of established futility stopping rules.
- Analysis of optimal timing based on information fraction and probability of stopping under the alternative hypothesis.
- Discussion of futility stopping in specific trial contexts.
Main Results:
- Identification and review of three key futility stopping rules.
- Recommendations for optimal futility look timing in two-stage trials.
- Exploration of challenges and strategies for futility stopping with outcome uncertainty and in crossover trials.
Conclusions:
- Futility stopping is a critical tool for efficient clinical trial conduct.
- Optimal timing of futility looks is crucial and depends on trial design parameters.
- Further research and clear guidelines are needed for complex trial designs involving futility stopping.
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