Track 11: Statistics
The theme of this track is, The Role of Statistics in Realizing the Goals of the 21st Century Cures Act and the PDUFA VI Commitments. With 11 sessions, the Statistics track will focus on topics of theoretical and practical interest to statisticians and clinical trialists who work with medical products, including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics throughout their lifecycle. Sessions will explore current statistical thinking which informs policy, regulation, development, review, and lifecycle management of medical products in the context of the current scientific and regulatory environments.
Sessions in Statistics
Monday, June 25
- Use of Historical Information in Clinical Trial Design
- Bayesian Application in Small-Sized Clinical Trials
Tuesday, June 26
- Pediatric and Rare Disease Drug Development
- Time-to-Event Analysis in Clinical Trials
- User-Friendly Tools for Study Planning and Analysis
- Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs
Wednesday, June 27
- Opportunities for Efficient and Innovative Study Designs
- Innovative Visualization Approaches
- Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints
- Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision-Making
Thursday, June 28
Who is This Track Designed For?
Professionals involved in: Statistics, biostatistics, statistical programming, clinical pharmacology, health economy, epidemiology, regulatory science, project management, and clinical development.