Dalla Lana School of Public Health

The Southern Ontario Chapter of the American Statistical Association (ASA) is pleased to announce the offering of an ASA Traveling Course entitled, Clinical Trials Using Master Protocol and Its Applications. This half day online course will be held on Friday, October 14th between 12:00 – 4:00pm EDT. Please see attached promotional flyer and registration link below. The Council of Chapters Traveling Courses provide low-cost courses for ASA Chapters.

Please register via Eventbrite: Clinical Trials Using Master Protocol and Its Applications

Instructors: Jingjing Ye, (BeiGene), Xiaoyun (Nicole) Li, (BeiGene), and Chengxing (Cindy) Lu (AstraZeneca)

Description:

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

a. Overview of master protocol: Definitions, Examples

b. Review of Regulatory Landscape: US and Rest-of-World regulatory guidance

c. 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

About the Instructors:

The confirmed instructors have given the short course in Deming Conference 2020 under the same title. Nicole and Cindy are the co-leads of Master Protocol sub-team under the ASA Biopharmaceutical Section Oncology Scientific Working Group (SWG) since 2018. Jingjing, Nicole and Cindy are the current co-leads of Joint DIA-ASA Master Protocol Working Group. The ASA WG manuscript “Practical guide and recommendations for master protocol framework: basket, umbrella and platform trials” is published on Therapeutic Innovation & Regulatory Science.

Please register via Eventbrite: Clinical Trials Using Master Protocol and Its Applications

If you have any questions, please contact Ryan Rosner at biostat.dlsph@utoronto.ca

Download: 2022 ASA Traveling Course – Clinical Trials Using Master Protocol and Its Applications