Sample size re-estimation in adaptive enrichment design

Clinical trial participants are often heterogeneous, which is a fundamental problem in the rapidly developing field of precision medicine. Participants heterogeneity causes considerable difficulty in the current phase III trial designs. Adaptive enrichment designs provide a flexible and intuitive solution. At the interim analysis, we enrich the subgroup of trial participants who have a higher likelihood to benefit from the new treatment. However, it is critical to control the level of the test size and maintain adequate power after enrichment of certain subgroup of participants.
Source: Contemporary Clinical Trials - Category: Radiology Authors: Source Type: research