A Regulatory View on Adaptive/Flexible Clinical Trial Design
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Recommendations
- Adaptive and flexible clinical trials
- A consultant's perspective on the regulatory hurdles to adaptive trials
- Some recent developments in the design of adaptive clinical trials
- Adaptive design methods in clinical trials
- Adaptation in clinical development plans and adaptive clinical trial designs
- On the efficiency of adaptive designs for flexible interim decisions in clinical trials
- Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
- Confirmatory clinical trials with an adaptive design
- Some optimal adaptive designs in clinical trials
Cited in
(9)- Practical and statistical considerations in designing an early phase II osteoarthritis clinical trial: a case study
- A consultant's perspective on the regulatory hurdles to adaptive trials
- Plan to be Flexible: A Commentary on Adaptive Designs
- Challenges and regulatory experiences with non‐inferiority trial design without placebo arm
- Ethics, data-dependent designs, and the strategy of clinical trials: time to start learning-as-we-go?
- Multicentre trials: a US regulatory perspective
- Multicentre trials: a US regulatory perspective
- Two-stage drop-the-losers design for the selection of effective treatments and estimating their average worth
- A varying-stage adaptive phase II/III clinical trial design
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