Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

The FDA Complex Innovative Trial Design Pilot Program: Case Examples

Session Chair(s)

Dionne  Price, PhD

Dionne Price, PhD

Deputy Director, Office of Biostatistics, OTS, CDER

FDA, United States

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

Speaker(s)

JonDavid  Sparks, PhD

Design and Statistical Considerations of a Proposed Master Protocol

JonDavid Sparks, PhD

Eli Lilly and Company , United States

Principal Research Scientist

Stephen  Lake, DrSc

Exploring Innovative Aspects of a Bayesian Adaptive Trial in Duchenne Muscular Dystrophy

Stephen Lake, DrSc

Wave Life Sciences, United States

Vice President, Biometrics

Laura Lee  Johnson, PhD

An Overview of Innovative Designs and Statistical Considerations:Lessons Learned

Laura Lee Johnson, PhD

FDA, United States

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER

John  Scott, PhD, MA

General Considerations of Complex Innovative Trial Designs

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.