Resolving challenges in adaptive oncological clinical trial design
The adaptive design concept is simple and compelling: You modify elements of the trial, such as dosage, sample size, patient selection criteria, and even endpoints, based on patient responses as they occur. The FDA encourages use of adaptive design by providing a more efficient regulatory review and evaluation process.
Adaptive design can save time and money and significantly reduce the patient sample size by focusing more and more narrowly on the subset of patients who benefit most from the therapy being studied. Ultimately, it can help you make critical go/no-go decisions earlier.
However, it adds even more complexity to an already challenging oncology trial. Our oncology team can help you select the best type of adaptive design study for your needs and stay on top of every decision you make. For example:
- Which study design?
- Which adaptations will increase the likelihood of a successful outcome?
- How do you most effectively manage monitoring and data capture?
- What are the selection criteria for patients who will benefit most from the therapy?
- Is the treatment promising enough to merit continued investment?