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Tuesday, June 16 • 2:00pm - 3:00pm
#239 L: The FDA Complex Innovative Trial Design Pilot Program: Case Examples

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-650-L04-P; CME 1.00; IACET 1.00; RN 1.00

A goal of the FDA Complex Innovative Trial Design Pilot Program is to facilitate the use of complex adaptive, Bayesian and other novel designs. This forum will present case examples from the Pilot Program and discuss FDA and industry interactions.

Learning Objectives

Describe examples of innovative clinical trials in the regulatory setting; Discuss regulatory and industry statistical interactions as a part of the CID Pilot Program


Dionne Price, PhD


Design and Statistical Considerations of a Proposed Master Protocol
JonDavid Sparks, PhD

Exploring Innovative Aspects of a Bayesian Adaptive Trial in Duchenne Muscular Dystrophy
Stephen Lake, DrSc

An Overview of Innovative Designs and Statistical Considerations:Lessons Learned
Laura Lee Johnson, PhD

General Considerations of Complex Innovative Trial Designs
John Scott, PhD, MA

avatar for Dionne Price

Dionne Price

Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section... Read More →
avatar for Laura Lee Johnson

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Stephen Lake

Stephen Lake

Vice President, Biometrics, Wave Life Sciences
Steve has 17 years of experience as a statistician in drug development. He is currently the Vice President of Biometrics at Wave Life Sciences. Prior to that he worked at Clementia Pharmaceuticals and for 14 years at Genzyme and Sanofi. He holds a Doctor of Science degrees in biostatistics... Read More →
avatar for John Scott

John Scott

Director, Division of Biostatistics, OBPV, CBER, FDA, United States
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored... Read More →
avatar for JonDavid Sparks

JonDavid Sparks

Principal Research Scientist, Eli Lilly and Company
JonDavid received his PhD in Biostatistics from the University of Iowa. He has been at Eli Lilly and Company for 10 years and has primarily worked in the areas of neuroscience, chronic pain, and Alzheimer's disease. He serves as a consultant across the neuroscience therapeutic area... Read More →

Tuesday June 16, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Forum