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Session 2: Clinical Trial Innovative Designs and Approaches – Setting the Context and Presenting the Industry Perspective
Session Chair(s)
Michelle Detry, PhD
Director, Adaptive Trial Execution & Senior Statistical Scientist
Berry Consultants LLC, United States
Innovation in clinical trials is an ongoing goal with a desired outcome of improving efficiency when investigating new therapies while maintaining the necessary scientific rigor for acceptance in clinical use as well as regulatory approval. Two general areas of innovation are the use of Master Protocols and seamless trial designs. This session will include one session discussing the use of Master Protocols to obtain trial efficiency and a second session discussing recent design innovations to facilitate efficient learning through seamless phase 2/3 and enrichment designs. The session will conclude with audience questions and discussion.
Learning Objective : - Identify the need for improvements in innovation in trial design and conduct
- Summarize in what manner Master Protocols improve efficiency in trial conduct
- Recognize the potential for efficient learning through use of seamless phase 2/3 or enrichment designs
Speaker(s)
Recent Design Innovation
Representative Invited
Berry Consultants LLC, United States
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