Track 11: Statistics
The Statistics track focuses on topics of theoretical and practical interest to statisticians and clinical trialists who work with medical products, including pharmaceuticals, biologics, biosimilars, cellular and gene therapies combination products, 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
Tuesday, June 16
Wednesday, June 17
- Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance
- Dynamic Multi-Disciplinary Collaboration for Aggregate Product Safety Assessment and Benefit-Risk Planning
- Using Data Monitoring Strategies in Detection of Data Anomalies and Trial Misconduct
Thursday, June 18
- Statistical Considerations for Using External Controls in Clinical Trials
- Opportunities and Challenges for Real World Data and Real World Evidence: Dive into the Details
- Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?
- Using Data Visualization to Drive Meaningful Insights
- Hype or Hope: Quantifying the Risk of Patients with Complex Diseases
- Utilization of Bayesian Statistics in Clinical Trials
- Best Practices for Randomization and Re-Randomization in Clinical Trials
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.