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A phase II flexible screening design allowing for interim analysis and comparison with historical control
Wenting Wu1, Brian Bot, Yan Hu
1Mayo Clinic and Mayo Foundation, Rochester, MN 55901, USA. wu.wenting@mayo.edu
Contemporary Clinical Trials
|May 28, 2013
Summary
This study enhances a flexible screening design for clinical trials by adding interim analysis and historical control comparisons. These modifications improve treatment selection and reduce patient exposure to ineffective therapies.
Area of Science:
- Clinical trial design
- Biostatistics
- Oncology drug development
Background:
- The original Sargent and Goldberg (SG) design offers a flexible approach for phase II trials.
- Selecting optimal regimens for phase III requires robust evaluation of multiple characteristics.
Purpose of the Study:
- To extend the SG design with interim analysis and historical control comparison capabilities.
- To enhance the identification of promising treatments with clinically meaningful efficacy.
- To reduce patient exposure to inferior treatment options.
Main Methods:
- Modification of the randomized phase II flexible screening (SG) design.
- Incorporation of interim analysis for early assessment.
- Inclusion of a historical control for efficacy benchmarking.
Main Results:
- Modified SG designs maintain moderate sample size increases.
- Substantially expanded utility of the flexible screening approach.
- Improved assurance of clinically meaningful treatment efficacy.
Conclusions:
- The modified SG designs offer a more comprehensive and efficient approach to phase II clinical trials.
- These enhancements provide greater confidence in treatment selection for phase III studies.
- The updated design balances statistical rigor with patient welfare.
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