April 28: Virtual Summit

This revamped one-day virtual event will present case studies and lessons learned from oncology and neuroscience, followed by roundtable discussions on master protocols, complex innovative designs (CIDs), and external data borrowing to assess bottlenecks and create solutions. Key findings, recommendations, and prioritized next steps will be published to drive continued collaboration.

Engage in vibrant group discussions with experts involved in clinical development, including biostatisticians, clinical researchers, technology experts, and regulators, and immerse yourself in cutting-edge insights—all from the comfort of your own space.

Key Agenda Highlights

This year’s summit emphasizes the importance of collaborations between regulators, industry leaders, researchers, and biostatisticians to enhance clinical trial efficiency and effectiveness.

Opening Remarks

Senior leaders from DIA, Pfizer, and the FDA set the stage for discussions on regulatory and scientific advancements in clinical trial design.

Regulatory Updates and FDA Initiatives

Overview of the FDA’s new Clinical Trial Innovation Initiative (C3TI), guidance on adaptive clinical trials (ICH E20), and insights on benefit-risk assessments for new drug and biological products.

Innovative Clinical Trial Designs

Exploration of Master Protocols and seamless phase 2/3 designs to improve efficiency in clinical trials, with industry perspectives on implementation challenges.

Case Studies on Novel Trial Approaches

(1) Master Protocols in Oncology – Practical examples of how these designs improve trial execution.

(2) Innovative Neuroscience Trials – Cutting-edge approaches to trial design in neurological disorders.

Challenges and Opportunities in Master Protocols – Focus on platform and basket trials, regulatory perspectives, and discussions on external data borrowing.

Implementation of Innovative Designs – Panel discussion on real-world challenges and best practices for applying innovative trial methodologies.