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- Date: Tuesday, April 16, 2024
- Time: 11 AM · EDT (5 PM CET)
- Webinar description:
Developing treatments for rare diseases pose many unique challenges that cannot be addressed by traditional study designs, including:
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- Prolonged enrolment periods and/or inability to enroll enough patients to formally power trials
- Lack of clarity regarding endpoints and key design assumptions due to limited relevant clinical trials experience
- Ethical concerns around the inclusion of a control arms.
These challenges require novel approaches, several of which will be reviewed and discussed during this webinar.
- Agenda:
- Informational Adaptive Design
- Use of External Controls
- Master Protocols
- Decision Making at Master Protocol and Portfolio Level
Short overview of presenter’s experience:
Zoran Antonijevic, Vice President of Statistical Consulting
He held executive positions in Pharmaceutical Companies and CROs and designed more than 100 clinical trials in numerous therapeutic areas, many of which included adaptive designs. Zoran was a long-time Chair and leader of the DIA Adaptive Design Scientific Working Group. He has authored numerous papers and scientific presentations and was editor of books “Optimization of Pharmaceutical R&D Programs and Portfolios” and, together with Bob Beckman, “Platform Trials in Drug Development”.