EUGM 2017: Biogen/Cambridge

Innovating Trial Design:  the East® User Group Meeting

The 2017 talks slides are now available.  We value your interest in the topics and heartily thank again all our expert speakers and our gracious Biogen Cambridge hosts.

EUGM 2017 Trial Design Symposia Slides

Matt Austin

Optimizing Geographic Site Distribution: Time/Cost Tradeoffs

thumb preso 5In collaboration with Vlad Anisimov, Matt Austin outlines Amgen's approach to the fundamental question "Where should we place the study that will enroll the fastest and cost the least?". How can trial planners successfully solve this core problem that only becomes more complex as a candidate progresses through the development process?

Bob Beckman
Georgetown University

Design Concept for a Confirmatory Basket Trial

thumb preso 5Bob Beckman from the Georgetown University's Medical Center presents his most recent research on balancing the theoretical and the practical considerations with basket trials. Bob begins by describing the more general design basket concept, then moves to recommendations on overcoming challenges in a more detailed manner.

Peng Sun

Novel Design and Implementation of Interim and Final Analyses in Sham-Controlled Double-Blinded Phase 3 Trial

thumb preso 5Biogen's own Peng Sun probes the thinking behind determining their analyses plan in developing a new Spinal Muscular Atrophy treatment.  Sun and colleagues considered the statistical issues for two related confirmatory trials for infantile and later onset of the disease.

Jim Bolognese

Adaptive Design and Trial Monitoring: a Practitioner's View

thumb preso 5Jim Bolognese, a Senior Director with Cytel Consulting examines Potential TRUE underlying Dose-Response Curves taking into account the Tolerability in addition to Efficacy. Jim also discusses the design comparisons of tolerability to active control, focusing on opioid-induced adverse effects.

Ed Whalen

Adverse Event Monitoring: Safety Statistics in Focus

thumb preso 5Pfizer's Ed Whalen begins with an overview of safety statistics in general for randomized controlled studies, observational studies, and spontaneous report data. 2) Examine recent changes in investigational new drug (IND) safety reporting. 3) Questions illustrating the need for improved methods to evaluate important side effects.

Cyrus Mehta

Multi-Arm Multi-Stage (MAMS) Trial Designs

thumb preso 5Cytel President and Co-Founder Cyrus Mehta presents his latest research on applying MAMS-designed trials in practice. Following an examination of the mathematical framework, he describes the considerations behind the adaptive design. consideration. Cyrus concludes with a comparison with alternative P-Value Combination designs.