DIA 2017 Annual Meeting

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Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development

Session Chair(s)

Theresa Crofts Ashton, PhD

Senior Director, Clinical Statistics

GlaxoSmithKline, United States

Master ("umbrella") protocols that have multiple treatment options are being used to optimize enrollment and expedite drug development based on biomarkers/specific disease traits. This session will discuss this approach and the benefits and challenges of these multi-company collaborations.

Learning Objective : Describe the Umbrella concept; Discuss key considerations.

Speaker(s)

The Use of Statistical Innovation to Increase Efficiency in Difficult-to-Enroll Clinical Trials

Kert Viele, PhD

Berry Consultants, United States

Director of Research. Senior Statistical Scientist

Combined Adaptive Early Phase Trials: From First-Time-in-Human to Proof of Concept in One Protocol

Ulrike Lorch, MD, FFPM

Richmond Pharmacology Ltd., United Kingdom

Medical Director

Beat AML: Practicalities and Lessons Learned From the Construct of a 10-Study Leukemia Umbrella Trial

Amy Burd, PhD

Eilean Therapeutics, United States

Chief Scientific Officer

Panelist

Nicholas Kenny, PhD

Syneos Health, United States