This subteam promotes computational methods with superior efficiency, clear interpretation and integrity in Phase 3 clinical development to efficiently deliver effective treatments to patients. Some topics are advanced multiplicity adjustment, practical group sequential / adaptive designs , protection of study integrity, data monitoring / insight generation, DMC-related activities, missing data handling, endpoint validation, benefit-risk assessment, causal inference, integration of multimodal data in regulatory submissions.
Jiangtao Gou (Villanova University) and Zhenzhen Xu (FDA)
Victoria Prince (Takeda), Jiarui Lu (Vertex).