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Wednesday, June 26 • 8:00am - 9:15am
#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.

Chair

Munish Mehra

Speaker

Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD



Speakers
MC

Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum