Optimizing Clinical Development With Adaptive Trial Designs
Stanley C McDermott
Managing Director, Clinical Research
Cardinal Health Regulatory Sciences, United States
Early-phase adaptive clinical trials combine multiple clinical objectives into one study to deliver high-quality data and substantial time and cost savings compared to a traditional approach involving several single-purpose studies. A biopharmaceutical developer needs to design a clinical strategy from product inception to regulatory approval that is tailored to meet clinical and regulatory expectations and is time- and cost-effective. This roadmap must detail the strategies for general clinical development, study design and operational execution and focus on a target product profile (TPP) that provides the product development team with valuable and measurable deliverables as well as the objectives for and guidance on the clinical development plan. The importance of having an in-depth understanding of adaptive clinical trial design and logistics is critical.
This interactive session will provide the framework for scientifically robust and efficient early-phase clinical drug development. Working with cross-functional teams and developing appropriate operational infrastructure for all stakeholders, including drug developers, clinical research organizations (CROs) and investigator sites, will also be highlighted.
Learning Objective : • Potential to reduce timelines and reduce unnecessary human exposure while increasing potential for
• Leveraging the accruing data to constantly fine tune the trial and decision making
• Investigating multiple clinical objectives by thoughtful planning and manage to be time- and cost-
Adaptive Trial Designs for Early Phase Clinical Development
Senior Director, Data Services, Clinical Pharmacology and PK, Early Dev Services
PRA Health Sciences, United States
The Range of Flexibility Being Shown in Clinical Trial Designs at the FDA in Oncology With Emphasis on Adaptive Trials
Mark Thornton, MD, PhD, MPH
Senior Clinical Consultant
Biologics Consulting, United States