Track 11: Statistics
This track will focus on topics related to the practice and application of statistical methods in medical product development 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.
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.
Included Topic Areas
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Statistics, biostatistics, Bayesian statistics, novel statistical tools, data standards, analysis and analysis sets, data interpretation, data visualization, trial planning and design, adaptive designs, innovative designs, model-informed drug development, data monitoring committees, precision medicine and subpopulation analysis, biomarkers, multi-regional clinical trials, endpoint assessment, real-world evidence, pragmatic trials, use of historical control, pediatric/rare disease drug development. Topics related to bioethical issues are also welcome and may be considered for a special track in the meeting.
- Complex Innovative Designs
- Safety and Benefit-Risk
- Application of Bayesian Methods in Drug Development
- Estimands
- Machine Learning and Use of Artificial Intelligence in Drug Development
- Patient-Focused Drug Development
- Causal Inference in Medical Product Development
- Communication and Collaboration
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