Agile clinical development--expanding the adaptive research concept to all clinical trial functions--may be the key to improving success rates for new drugs. Michael Rosenberg, CEO at Health Decisions, says in a new book that each study is unique and requires its own mix of adaptations, both design and operational. Researchers need to identify and implement the adaptations to boost trial efficiency.
The 304-page Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development, published by John Wiley & Sons, includes case histories that illustrate the integration of adaptive design and adaptive operations. The book sells for $79.95. Rosenberg is also co-author of Clinical Trials Handbook, a guide to adaptive clinical trial best practices, as reported last August.
A survey last May by Perceptive Informatics and Cytel showed that sponsor concerns about regulatory acceptance, new techniques, and access to clinical endpoint data remain barriers to the still more hyped than practiced use of adaptive techniques in clinical trial design.
- here's the announcement