All Times EDT
Keywords: adaptive design, practical implementation, industry, innovative, complex
In the past years, there has been increased attention on use of adaptive design in clinical trials. Adaptive design can potentially reduce the average sample size or duration of the study, and lead to more efficient clinical trials with reduced cost. Besides, many adaptive designs now have well-established methodologies to control type I error rate appropriately. However, in practice, the adoption of adaptive design is not as much as one may expect. In this roundtable, we will discuss case studies and your experience in the challenges of implementing an adaptive design in real-world practice. It may include but not limited to: • The handling of patient overflow • Availability of simulation tools • Regulatory acceptance • Communication efficiency between sponsors and agencies • Challenges in use of short-term, intermediate endpoint(s) for adaptation decision