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Welcome to the Northeastern Illinois Chapter

American Statistical Association

The 2022 short course will be held on May 13, 2022.

Title
: Clinical Trials Using Master Protocol and Its Applications

Date: May 13, 2022 9:00 am - 1:00 pm CDT

Location: Zoom / Remote (sent after registration)

Registration: $25 
https://www.eventbrite.com/e/clinical-trials-using-master-protocol-and-its-applications-tickets-305976372567

Instructors: Jingjing Ye1, PhD, Xiaoyun (Nicole) Li2 ,PhD, Chengxing (Cindy) Lu3 ,PhD

  1. BeiGene, ye@beigene.com; 2 BeiGene, Nicole.li@beigene.com; 3. AstraZeneca, cindy.lu3@astrazeneca.com

 

Abstract:

As the paradigm of drug development shifts to personalized medicine and targeted therapies, pool of eligible clinical trial patients becomes increasingly smaller and there is a need for rapid learning and confirmation of clinically meaningful treatment effect. Master protocol, including umbrella, basket, and platform trials, promotes innovation in clinical trials and aims at improving efficiency, avoiding duplication and competition, and accelerating the drug development process. Though master protocols used to be primarily sponsored by nonprofit organizations, academic institutes and government agencies mostly in oncology area, there is a growing trend of conducting clinical trials using master protocol in recent years from the pharmaceutical industry in oncology and other therapeutic areas. Regulatory agencies across the globe have issued guidance on master protocols. In 2018, the ASA Biopharmaceutical Section Oncology Scientific Working Group (SWG) was chartered to explore innovative statistics in oncology drug development and a sub-team on master protocol in oncology was formed. In this short course, instructors from the Oncology SWG master protocol sub-team will provide an overview on master protocol, its regulatory landscape, statistical methodologies, special statistical considerations, challenges and opportunities both statistically and operationally. The last part of this short course will include a case study of a COVID platform trial: RECOVERY Trial, with detailed illustrations on how to implement the considerations discussed in the earlier part of the short course. See below the structure of the short course:

 

Part 1: Overview of master protocol

  1. Overview of master protocol: Definitions, Examples
  2. Review of Regulatory Landscape: US and Rest-of-World regulatory guidance
  3. Practical Considerations

 

Part 2: Novel statistical methodologies used in master protocol trials, statistical and operational consideration

 

Part 3: Case Study of a COVID platform trial: RECOVERY Trial

 




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