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Session 1:Promoting Complex Innovative Trial Designs: An Update and Discussion on the Pilot Meeting Program
Session Chair(s)
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States
Cristiana Mayer, DrSc, PhD
Head of Biostatistics
Johnson & Johnson Vision, United States
Amy Xia, PhD
Vice President, Center for Design and Analysis
Amgen Inc., United States
As a deliverable under the Prescription Drug User Fee Amendments of 2017, the FDA launched the Complex Innovative Trial Design (CID) Pilot Meeting Program on August 29, 2018. The purpose of the program is to facilitate the advancement and use of complex adaptive, Bayesian, or other innovative clinical trial designs requiring simulations to determine operating characteristics. This session will give an update on the CID Pilot Meeting Program including a case study and provide a perspective on best practices for simulations in support of CID. Additionally, a group of speakers and panelists will discuss opportunities and challenges relative to the continued implementation of the program.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain the concept of CID and the role of simulations in CID
- Present a case study
- Describe challenges and opportunities in applying CID
Speaker(s)
Speaker
Dionne Price, PhD
FDA, United States
Deputy Director, Office of Biostatistics, OTS, CDER
Speaker
Telba Irony, PhD, MS, MSc
Janssen R&D, United States
Senior Scientific Director, Quantitative Sciences
Industry Perspective on the Simulation Practices for Complex Innovative Designs
Vladimir Dragalin, PhD
Janssen R&D, at Johnson & Johnson, United States
Vice President, Scientific Fellow