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Patient selection for phase II trials
Guru Sonpavde1, Matthew D Galsky, Thomas E Hutson
1Texas Oncology, P.A., Dallas, Texas, USA. guru.sonpavde@usoncology.com
American Journal of Clinical Oncology
|April 7, 2009
Summary
Standard phase II trials often produce inconsistent results due to varied patient populations. A proposed multicenter approach with strict patient selection may improve trial validity and guide drug development more effectively.
Area of Science:
- Clinical trial design
- Oncology research
- Drug development
Background:
- Standard phase II trial designs often yield inconsistent results, partly due to variable patient populations.
- These designs can be poor predictors of efficacy in subsequent phase III trials.
- Alternative designs like randomized phase II trials require more resources and patients without being definitive.
Purpose of the Study:
- To propose an improved phase II trial paradigm for more reliable drug development.
- To enhance the validity and reproducibility of phase II trial outcomes.
- To identify more effective regimens for phase III evaluation.
Main Methods:
- Proposing a paradigm shift towards multicenter straight phase II trials.
- Emphasizing rigorous patient selection criteria within these trials.
- Comparing the proposed model to single-center trials with selected populations.
Main Results:
- Multicenter phase II trials with strict patient selection are hypothesized to yield more valid and reproducible results.
- This approach is suggested to be a superior guide for selecting regimens for further development compared to single-center trials.
- The proposed design aims to mitigate issues arising from patient population variability.
Conclusions:
- A multicenter, straight phase II trial design with rigorous patient selection offers a more robust approach to early-phase drug evaluation.
- This paradigm can improve the reliability of results, aiding in the selection of promising regimens for phase III studies.
- The proposed methodology addresses limitations of standard and other alternative phase II trial designs.
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