Estimand Framework Implementation

Mon, Aug 7, 8:30 AM

Lamar HuntChair

Biopharmaceutical Section

6 Presentations

Application of Estimand Framework in ICH E9 (R1) to Safety Evaluation

8:35 AM - 8:50 AM

Xuelong Wang

Co-authors: Ping Yang (MSD China Holding Co.), Sammy Yuan (GSK), William Wang (BARDS, Merck Research Labs)

CITIES: Clinical Trials With Intercurrent Events Simulator

8:50 AM - 9:05 AM

Ahmad Hakeem Abdul Wahab (Janssen)

Co-authors: Yongming Qu (Eli Lilly and Company), Hege Michiels, Junxiang Luo (Moderna), Run Zhuang (Purdue University), Dominique McDaniel, Dong Xi (Gilead Sciences), Elena Polverejan (Johnson & Johnson-Janssen R&D), Steven Gilbert, Stephen Ruberg (Analytix Thinking, LLC), Arman Sabbaghi (Purdue University)

Design and Analysis of Phase I/II Pediatric Clinical Trials in the Era of Estimands

9:05 AM - 9:20 AM

Bryan Nelson (Harvard University)

Co-authors: Kristin Baltrusaitis (Harvard T.H. Chan School of Public Health), Sean Brummel (Harvard T.H. Chan School of Public Health), David Shapiro (Harvard TH Chan School of Public Health), Camlin Tierney (Harvard School of Public Health), Jiajia Wang (Harvard T.H. Chan School of Public Health), Linda Harrison (Harvard TH Chan School of Public Health), Dwight Yin (DAIDS), Pearl Samson (SDAC-Frontier Science/Harvard School of Public Health), Grace Montepiedra (Harvard T.H. Chan School of Public Health)

Estimand Framework and Its Implementation to Oncology

9:20 AM - 9:35 AM

Yu Ding (Merck & Co., Inc.)

Co-authors: Liyi Jia (Merck & Co, Inc.), Fang Liu, Ke Chen (Merck & Co., Inc.), Ruixue Wang

Estimand Framework for Per Protocol Analysis in Non-Inferiority and Bioequivalence Clinical Trials

9:35 AM - 9:50 AM

Mohsen Rezapour Toughari (Vertex)

Co-authors: Nitin Nair, Rachel Zahigian, Bingming Yi (Vertex)

Statistical Considerations for Randomized Clinical Trials Design under the Estimand Framework

9:50 AM - 10:05 AM

Helen Bian

Co-authors: Nan Sun (Bristol-Myers Squibb), Jixian Wang (Bristol Myers Squibb), Sandra Zhang (BMS), Tina Young (AbbVie)

Session participants

Elena Polverejan (Johnson & Johnson-Janssen R&D)

Participant