Meeting Program

This three-day program will give attendees the opportunity to interact with speakers, global regulatory agency personnel and other participants in a dynamic and informative environment. Sessions will feature presentations, panel discussions, and Q&A.

Session Topics

  • PDUFA V Overview
  • Statisticians as Leaders
  • FDA Upcoming Guidance Update (Multiplicity and Enriched Populations) 
  • Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks
  • Measures for Primary Efficacy Endpoint – Are we Substantially Compromising Statistical Power?
  • Pre-Competitive Collaboration
  • Meta Analysis for Safety Data
  • Companion Diagnostics
  • (Pre-Marketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review 
  • (Pre-Marketing) Benefit-Risk Assessments
  • Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies
  • Missing Data: When is it Important to Collect Data After Study Drug Discontinuation?
  • Missing Data: Case Study Presentation and Panel Discussion
  • Overview and Commentary of FDA Guidances:  Multiplicity and/or Enriched Populations

Tutorial Topics

  • Statistical Methods for Safety Surveillance
  • Benefit-Risk Evaluation
  • Missing Data in Clinical Trials

Who Should Attend

  • Statisticians
  • Clinicians
  • Epidemiologists
  • Pharmacometricians
  • Drug safety professionals
  • Regulatory and medical communication scientists

DIA/FDA Statistics Forum 2013


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