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Contributed Papers

Statistical Borrowing Approaches in Clinical Trials

Sun, Aug 6, 4:00 PM

Gaurav SharmaChair

Biopharmaceutical Section

5 Presentations

Statistical Challenges in Borrowing External Data in a Pivotal Study for a Rare Disease

4:05 PM - 4:20 PM

Meng Liu (Vertex Pharmaceuticals)

Co-authors: Tu Xu, Bingming Yi (Vertex), Tu Xu, Yuansong Zhao

Borrowing Phase 2 Data in Phase 3: The PUNCH CD3 Trial.

4:20 PM - 4:35 PM

Joseph Marion (Berry Consultants, LLC)

Co-authors: Scott Berry (Berry Consultants)

Statistical modeling for information borrowing in oncology trials for rare disease

4:35 PM - 4:50 PM

Deepak Nag Ayyala (Takeda Pharmaceuticals)

Co-authors: Cassie Dong, Deepak Nag Ayyala (Takeda)

Evaluation of Dynamic Borrowing Approaches in Phase III trials

4:50 PM - 5:05 PM

Sourav Mukherjee (Bristol Myers Squibb)

Co-authors: Archie Sachdeva (Bristol Myers Squibb), Liping Huang (Bristol Myers Squibb), Arun Kumar (Bristol Myers Squibb), Ram Tiwari (Bristol Myers Squibb), Kaushal Mishra, Kalyanee Viraswami-Appanna (Bristol Myers Squibb)

Robust Historical Data Borrowing for Survival Studies

5:05 PM - 5:20 PM

Frank Shen (BMS)

Co-authors: Emmanouil Spanakis (AbbVie Deutschland GmbH & Co. KG), Min Chen

Session participants

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

Participant

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