Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 148 - Master Protocols in Oncology Drug Development
Type: Invited
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 11:50 AM
Sponsor: ENAR
Abstract #309436
Title: ASA Oncology Working Group Sub-Team Report on Oncology Master Protocols
Author(s): Chengxing (Cindy) Lu* and Xiaoyun (Nicole) Li
Companies: Biogen Inc. and Merck
Keywords: Master protocol ; Oncology; Complex Trial Design; Best Practices; Regulatory engagement; Information borrowing

The American Statistical Association (ASA) oncology working group was chartered in 2019 to explore innovative statistical topics in oncology drug development and a sub-team on master protocol was formed subsequently. In this sub-team, leaders across the industry, academia and regulatory join their experiences regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overarching trial structure, known as a master protocol. More specifically, views on best practices in designing and implementing such complex trials are shared and confirmed; experiences on strategic engagements with world-wide regulators and their feedbacks are exchanged and compiled; various statistical methods that allow borrowing information within the trial and best utilizing the data are reviewed and evaluated. This presentation will provide an update with respect to the above-mentioned aspects.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2020 program