Please join David Burrow from the FDA’s Center for Drug Evaluation and Research (CDER) as he discusses the transformation of clinical research and the advancement of drug development and clinical trial design. David will share perspectives on various clinical trial innovation activities including evolving study designs (e.g., master protocols), operational approaches (e.g., decentralized clinical trials (DCT)), and data sources (e.g., real-world data (RWD)). Hear directly from CDER’s Office of Compliance on balancing the critical interests involved in supporting innovation in clinical research along with the FDA’s role as a global regulatory and enforcement agency focused on protecting public health.

Speaker

• David Burrow, PharmD, JD
  Director, Office of Scientific Investigations
  Office of Compliance, CDER
  FDA

Event Agenda

• 5:00 – 5:15 pm – Registration and sign-in
• 5:15 – 6:00 pm – Presentation
• 6:00 – 6:30 pm – Q&A and Networking

Learning Objectives

• Explore Innovations in Clinical Trials – Gain insights into emerging clinical trial designs, such as master protocols, and operational approaches like decentralized clinical trials (DCT).
• Understand the Role of Real-World Data (RWD) – Learn how real-world data is shaping drug development and regulatory decision-making.
• Navigate Regulatory Compliance & Innovation – Hear from CDER’s Office of Compliance on balancing clinical trial innovation with the FDA’s mission to protect public health through regulatory oversight and enforcement.

Register + Learn More