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Controlling the family-wise error rate in multi-arm, multi-stage trials
Luis A Crouch1, Lori E Dodd2, Michael A Proschan2
11 Department of Biostatistics, University of Washington, Seattle, WA, USA.
Clinical Trials (London, England)
|May 27, 2017
Summary
Multi-arm, multi-stage trials can improve clinical trial efficiency. This study introduces a simple design that controls the family-wise error rate, reducing sample size without sacrificing statistical power.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Drug Development
Background:
- Multi-arm, multi-stage (MAMS) trials are gaining traction for enhanced clinical trial efficiency.
- Existing MAMS designs often overlook multiplicity issues, leading to type I error rate inflation.
- A need exists for efficient MAMS designs that rigorously control statistical error rates.
Purpose of the Study:
- To propose a straightforward MAMS trial design.
- To control the family-wise error rate (FWER) in MAMS trials.
- To improve trial efficiency, measured by reduced sample size and time.
Main Methods:
- Developed an analytical method to calculate FWER for MAMS trials.
- Proposed a novel MAMS design to control FWER.
- Included methods for computing statistical power and expected sample size.
Main Results:
- The proposed method effectively controls FWER across various MAMS designs.
- The design significantly reduces the expected sample size compared to uncontrolled designs.
- Adequate statistical power is maintained while controlling the error rate.
Conclusions:
- MAMS designs offer substantial reductions in clinical trial time and resources.
- The proposed simple design achieves efficiency gains while controlling FWER.
- This approach minimizes power loss, making it a practical option for trial optimization.
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