Concurrent Roundtable Discussions

Back to Agenda

Concurrent Roundtable Discussions

Session Chair(s)

Representative Invited

DIA, United States

Based on the attendees’ topic preference, which will be collected during the registration process, the room will be separated into three sections – one for each of the three topics: 1) Master Protocols; 2) Innovative clinical Trial Design Methodology, and 3) Borrowing of Data. Once in their selected section of the room, attendees will join one of the pre-set large roundtables for the discussion. Each individual table will have 10 seats including a moderator. The DIA Team and Program Committee have prepared a list of questions for discussion on each topic. Table participants will be able to add on to the list during the roundtable discussion.

I. Master Trial Protocols: Platform, Umbrella and Basket

II. Innovative Trial Designs

This discussion will focus on lessons learned in the design, conduct and analysis of Platform and Basket Trials, including the challenges encountered and opportunities in accelerating development of finding appropriate indications for promising new treatment. As per the FDA Guidance “Basket Trials are designed to evaluate a medical product for multiple diseases, conditions, or disease subtypes. Clinicaltrials.gov lists 71 , most in oncology and most in early Phase development. Basket trials have the potential to confirm safety and detect early signals of efficacy across different indications or cohorts of patients. In addition to oncology, basket trials are also used in neurological and autoimmune diseases.

III. Borrowing of Data

Speaker(s)

I. Master Trial Protocols: Platform, Umbrella and Basket - Moderator

Munish Mehra, PhD, MS, MSc

Quantum Biopharma, United States

Managing Director and Sr. Principal Biostatistician

I. Master Trial Protocols: Platform, Umbrella and Basket - Moderator

Representative Invited

FDA, United States

I. Master Trial Protocols: Platform, Umbrella and Basket - Moderator

Maria Vassileva, PhD

DIA, United States

Chief Science and Regulatory Officer

II. Innovative Trial Designs - Moderators

Pabak Mukhopadhyay, PhD

AstraZeneca, United States

Executive Director, Late Statistics, Head of Breast Cancer Strategy

II. Innovative Trial Designs - Moderators

Sandra Blumenrath

DIA, United States

Managing Editor, Scientific Publications

II. Innovative Trial Designs - Moderators

Representative Invited

FDA, United States

III. Borrowing of Data - Moderator

Representative Invited

FDA, United States

III. Borrowing of Data - Moderator

Representative Invited

Amgen, United States

III. Borrowing of Data - Moderator

Stephanie Rosner, MA, PMP

DIA, United States

Scientific Program Manager, Artificial Intelligence

Have an account?

Biostatistics and Clinical Innovation Industry and Regulator Forum