Virtual Event
2025 年 04 月 28 日 9:00 上午 - 2025 年 04 月 28 日 5:15 下午
(US Eastern Standard Time)
Fort Washington, PA 19034
Gain access to novel, thought-provoking findings and collaborate with experts on charting the best path forward in biostatistics and clinical trial innovation.
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Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Session Alignment for 2025!
The FDA has played a major role in guiding and collaborating with researchers to promote the efficient and safe development of drugs. This session focuses on regulatory updates, including a new FDA’s initiative and two recently published FDA guidance documents for industry on the design and conduct of clinical trials.
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.
This session will showcase two compelling case studies highlighting innovative approaches to clinical trial design and execution. Each case study provides a deep dive into real-world applications, focusing on the challenges, solutions, and outcomes of cutting-edge methodologies in diverse therapeutic areas.
Master protocol case studies in oncology will be discussed. A practical example of effective master protocol design and execution will be presented. Regulatory opinions on implementation and evaluation will also be discussed.
