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Printable Handouts
Navigable Slide Index
- Introduction
- Presentation outline
- Why multiple or composite efficacy endpoints?
- Sources of multiplicity in clinical trials
- Monte-Carlo estimates of type I error rate inflation
- Ideal situation - confirmation trials
- Single endpoint may not be possible/preferred (1)
- Single endpoint may not be possible/preferred (2)
- Single endpoint may not be possible/preferred (3)
- Multiple endpoints in selected disease areas
- Composite endpoint types - catagorical
- Composite endpoint types - continuous
- Motivations for use of composite endpoints
- Decision-making scenarios under multiplicity
- Decision-making scenarios (i) ...
- Example: alfuzosin in BPH
- Power loss for wining in all K endpoints
- Sample size multiplier - 80% overall power
- Decision-making scenarios (ii) ...
- Example: rimonabant in obese diabetics
- Decision-making scenarios (iii) ...
- Decision-making scenarios (iv) ...
- Example: xaliproden in ALS
- Why different methods for addressing multiplicity?
- Decision-making scenarios - composite endpoint
- Examples of CE in allergic hinitis
- Holm step-down procedure
- Hochberg step-up procedure
- Example 1 - Bonferroni modified procedures
- Example 2 - Bonferroni modified procedures
- Example 3 - Bonferroni modified procedures
- Two-stage statistical tests conclusions
- Two-stage testing 3 methods
- Complete closure for 4 endpoints
- Properties of global tests - power performance
- Properties of global tests - 7 test statistics
- 5 power performance tests
- Simulated adjusted nominal levels
- Well-known properties of global tests
- Global test formulas
- Critical Zalpha/2 values for K correlated endpoints
- Conclusions
- Additional references
Topics Covered
- The complexities of a clinical trial with multiple objectives and/or therapeutic areas where the disease manifests itself in a multi-faceted manner
- Reasons for and the common sources of multiplicity in clinical trials
- The associated clinical and statistical approaches for controlling the probability of incorrectly declaring a treatment benefit
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Talk Citation
Sankoh, A. (2007, October 1). Handling multiplicity due to multiple primary or composite endpoints in clinical trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 13, 2024, from https://doi.org/10.69645/GHUP4380.Export Citation (RIS)
Publication History
Financial Disclosures
- Dr. Abdul Sankoh has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Handling multiplicity due to multiple primary or composite endpoints in clinical trials
A selection of talks on Methods
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