Enhancing Adoption of Innovative Clinical Trial Approaches

Speaker(s)

Moderator: Meghana Chalasani, MHA, CDER, FDA, Silver Spring, MD, USA
Panelists: Kevin Bugin, PhD, CDER, FDA, unknown, DC, USA; Robyn Bent, MS, RN, CDER, FDA, Silver Spring, MD, USA; Christian Nguyen, MBA, US Health Outcomes, Eli Lilly & Co., Indianapolis, IN, USA; Sara Bristol Calvert, PharmD, Clinical Trials Transformation Initiative, Durham, NC, USA

ISSUE:

Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

OVERVIEW:

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Its goal is to promote existing CDER programs and spur future clinical trial innovation activities through enhanced communication and collaboration. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. They will also introduce C3TI's demonstration program, which focuses on Bayesian supplementary analyses, selective safety data collection, and streamlined trials embedded in clinical practice as initial project areas. The FDA presenters will be joined by academic and industry speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Code

104

Topic

Study Approaches