Track 11: Statistics
This track will focus on topics of practical and theoretical statistical interest for professionals who work with medical products, including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics throughout their lifecycle. Sessions will explore topics related to current statistical thinking which inform policy, regulation, development, review, and lifecycle management of medical products in the context of the current scientific and regulatory environments. A new aspect of the track is data science, a multidimensional area with the two major dimensions of curation and analysis. This track is focused on the analysis dimension, including analytics and predictive analytics.
Sessions in Statistics
Monday, June 28
- Statistical Considerations with the Patient in Mind
- Hiding in Plain Sight: Quantifying Underdiagnosed Populations
- Regulatory, Industry, and Academic Perspectives on Machine Learning in Clinical Trials
Tuesday, June 29
- Building on Opportunities from a Pandemic to Influence the Future of Clinical Research
- Innovative Statistical Strategies and Designs in Oncology Drug Development
- A Regulatory/Industry Panel on Estimands: Alignment of the Clinical Objective, Trial Design, Analysis, and Interpretation
Wednesday, June 30
- Clinically Meaningful: How is it Different from Statistical Significance?
- Mixing Modes of Clinical Outcome Assessments in Response to COVID-19
- Global Harmonization of Complex and Innovative Trial Designs
Thursday, July 1
- Fairness and Bias Detection and Mitigation in Machine Learning Algorithms: Real-World Evidence Applications and Examples
- The Journey to a Modernization of Analytics
- Population Diversity Considerations in Clinical Trials
Who is This Track Designed For?
DIA recommends this track for: Biostatisticians, data scientists (analytics), statistical programmers, clinical pharmacologists, health economists, epidemiologists, regulatory scientists, physicians, project leaders, and other clinical development practitioners.