Wednesday, March 25, 2009

Announcement: Sessions Selected for Inclusion in the 2009 FDA/Industry Statistics Workshop

The following sessions* (presented in no particular order) have been selected for inclusion in the 2009 FDA/Industry Statistics Workshop. Session organizers please see blog post on "Timeline for Session Organizers"

Plenary Sessions (90 minutes):
1. Future Directions in Planning Safety Analysis and Risk Management
2. Regulatory Issues in Global Harmonization of Clinical Studies
3. The World is (almost) Flat: Statistical Considerations as Clinical Development goes Global

Concurrent Sessions (75 minutes):
1. PK/PD Model-based Drug Development
2. Adaptive Design – Theory and Methods
3. Adaptive Design: Applications and Examples
4. Longitudinal Analysis, Missing Data and Assessment of Durability of Treatment Effect
5. Effective Use of Interim/Futility Analysis: A Case Study and Regulatory Considerations
6. Evaluation of Efficacy and Safety in the Presence of Subgroup Heterogeneity
7. Survival Analysis-Issues related to Follow-up in Time to Event Endpoints
8. Bayesian Methods throughout the Lifecycle of Medical Products
9. Multiplicity Adjustment in Clinical Trials with Multiple (Primary and Secondary) Endpoints: Issues and Concerns
10. Meta Analysis with a Focus on Safety
11. Design and Analysis for Non-InferiorityTrials – A Practical Perspective
12. Biomarkers in Drug-diagnositic Co-development
13. Endpoint Issues in Oncology
14. Recent Issues in CNS Drug Development
15. Views on Integrated Summary of Effectiveness and Integrated Summary of Safety: From FDA and Industry Perspective
16. Effective Communication and Collaboration between FDA and Industry Statisticians in the Regulatory environment
17. Quantitative Approaches to Decision Making in Clinical Development
18. Design Issues in Clinical Trials: From Randomization to Assay Sensitivity
19. Food Safety and Validation method
20. Veterinary Medicine I – Design and Analysis
21. Veterinary Medicine II – Issues in Target Animal Safety Studies
22. Medical Devices- Aspects of missing data unique to medical device trials
23. Post-Approval Issues for Diagnostic Devices
24. Statistical Issues in Vaccine Clinical Trials

Special Interest Forum : Avoiding Type III Errors in CMC Statistical Methods

* Program is preliminary and subjected to change

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