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 various 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 24
- Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
- Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
- How Statistics Can Help Improve Data Quality: ICH E6 R2
Tuesday, June 25
- Real World Data to Real World Evidence
- Artificial Intelligence Enhanced Data Analytics for Clinical Trials
- Master Protocols: Applications in Oncology
- Clinical Safety Assessment: What’s a Statistician Got to do with It?
Wednesday, June 26
- Implementation of Innovative and Adaptive Designs in Clinical Trials
- Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine
- Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
- Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
- Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Take a look at one of our podcast interviews from DIA 2018 as Members of the Safety Working Group of the Biopharmaceutical Section of the American Statistical Organization focus on statistical strategies for obtaining reliable evidence from sources of safety data.
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.