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The Use of the Puzzle Box as a Means of Assessing the Efficacy of Environmental Enrichment
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Adaptive enrichment designs for confirmatory trials.
Tze Leung Lai1,2,3, Philip W Lavori1,2, Ka Wai Tsang3
1Department of Statistics, Stanford University, Stanford, California.
Statistics in Medicine
|October 3, 2018
Summary
This study reviews adaptive enrichment designs for clinical trials, advancing strategies for drug and biologic approval. It applies these designs to a stroke trial comparing new endovascular treatments to standard care.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
- Neurology
Background:
- The Food and Drug Administration (FDA) issued draft guidance in 2012 on enrichment strategies for clinical trials.
- Enrichment designs aim to improve trial efficiency and the ability to detect treatment effects.
Purpose of the Study:
- To provide an overview of the FDA's 2012 draft guidance on enrichment strategies.
- To describe advances in adaptive enrichment designs for clinical trials.
- To illustrate the application of adaptive enrichment designs in a real-world clinical trial setting.
Main Methods:
- Review of FDA guidance and literature on adaptive enrichment designs.
- Description of adaptive enrichment design principles.
- Application of enrichment design to the Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution 3 (VISTA-3) trial.
Main Results:
- Advances in adaptive enrichment designs offer more flexible and efficient trial methodologies.
- The VISTA-3 trial serves as a practical example of implementing an enrichment design.
- Enrichment strategies can enhance the evaluation of novel treatments.
Conclusions:
- Adaptive enrichment designs represent a significant advancement in clinical trial methodology.
- These designs are crucial for optimizing the evaluation of new drugs and biologics.
- The VISTA-3 trial demonstrates the feasibility and potential benefits of applying enrichment strategies in stroke research.
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