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Wednesday, June 26 • 8:00am - 9:15am
#304: Operationalizing Master Protocols

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-660-L04-P; CME 1.25; IACET 1.25; RN 1.25

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master protocols (including basket, umbrella, and platform trials) provide a method to answer multiple questions in one overarching trial structure. Although these trials require more intentional planning, coordination and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial.

In this session, we consider this emerging family of clinical trial designs within the context of broader efforts to increase efficiency, effectiveness, and quality in the development paradigm.

Learning Objectives

Analyze different trial designs that can be described and executed under a master protocol (including umbrella, basket and platform); Describe considerations and challenges for master protocol development; Discuss a case example for using the common protocol template basket studies; Identify critical elements around data collection, analysis, and interpretation;


MaryAnn Morgan-Cox, PhD


Master Protocols; Design and Execution Considerations
Meredith Buxton, PhD, MPH

Utilizing the TransCelerate Common Protocol Template for Novel Clinical Trial Designs, Such as Platform Trials
Mitzi Allred, PhD

Statistical Analysis Opportunities and Challenges with Master Protocols
Karen Lynn Price, PhD, MA

avatar for Mitzi Allred

Mitzi Allred

Director Clinical Operations; Head, Clinical Content Standards, Merck Sharpe & Dohme, Co., Inc.
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →
avatar for Meredith Buxton

Meredith Buxton

Chief Operating Officer, Global Coalition For Adaptive Research
Meredith provides operational leadership for the Global Coalition for Adaptive Research (GCAR), a nonprofit research organization founded to expedite the discovery and development of cures for patients with rare and deadly diseases, and home of GBM AGILE, an international, seamless... Read More →
avatar for MaryAnn Morgan-Cox

MaryAnn Morgan-Cox

Senior Director, Immunology Design Hub, Eli Lilly and Company
MaryAnn Morgan-Cox is a Sr Director and Leader of the Immunology Design Hub at Eli Lilly and Company, where she focuses on innovative approaches to drug development, clinical research, commercialization, and portfolio management.
avatar for Karen Price

Karen Price

Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis... Read More →

Wednesday June 26, 2019 8:00am - 9:15am
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA