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.
Included Topic Areas in Statistics
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Benefit-risk at the subgroup and patient level
- Novel data visualization applications
- Using real world evidence for regulatory decision-making
- Use of historical controls in clinical trials
- Drug development informed by the “Patient Voice”
- Orphan drugs/rare diseases/pediatric drug development
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.