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Novel Study Designs for Rare Diseases: Maximize the Efficiency of Your Development Programs
About This Webinar
Developing treatments for rare diseases pose many unique challenges that cannot be addressed by traditional study designs, including:
1) Prolonged enrolment periods and/or inability to enroll enough patients to formally power trials
2) Lack of clarity regarding endpoints and key design assumptions due to limited relevant clinical trials experience
3) 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
Who can view: Everyone
Webinar Price: Free
Featured Presenters
VP, Statistical Consulting
Zoran Antonijevic is Vice President of Statistical Consulting at Bioforum. 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”.
COO, Bioforum
Amanda has over 25 years of operational and commercial experience in the clinical trial industry at both pharmaceutical companies and CROs, with a particular focus on biometrics. An accomplished leader with a background in statistics, she brings broad experience in data acquisition, refinement, analysis, and reporting, and specializes in optimizing processes, crafting cost-effective solutions, and prioritizing data quality.
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