Dear Fellow Statisticians,
We are pleased to announce an exciting seminar on clinical trial innovation as part of the ISBS Webinar Series. The seminar, titled " Use of Real-World Data and Real-World Evidence in Rare Disease Drug Development " will be held on March 14, 2025, 10am-11pm EST, featuring distinguished speaker Dr. Jie Chen from Taimei Intelligence Clinical Research.
Abstract:
Real-world data (RWD) and real-world evidence (RWE) have been increasingly used in medical product development and regulatory decision-making, especially for rare diseases. After outlining the challenges and possible strategies to address the challenges in rare disease drug development, this presentation, based on work by the ASA BIOP RWE Scientific Working Group, will discuss the roles of RWD and RWE in clinical trials for drugs treating rare diseases. A targeted learning roadmap for rare disease trials is described, followed by case studies on the use of RWD and RWE to support a natural history study and marketing applications in various settings.
Registration Details:
Please register using the following link:
https://us06web.zoom.us/meeting/register/fBX4cilaSPirz4YhenqX4Q
We look forward to your participation on March 14!
Best Regards,
Haitao Pan, on behalf of ISBS Webinar Committee
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Haitao Pan
Associate Professor
St. Jude Children's Research Hospital
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