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Consensus Conference Topics

(established in Advisory Board Meeting, 2-28-00):

  1. Incorporating uncertainty into the design of clinical research - preclinical phase, phase I, phase II, and phase III
  2. Using surrogate endpoints in clinical research
  3. How to use adaptive methods to improve the efficiency of phase II/III trials
  4. Determining whether and when to enter phase III of a clinical trial
  5. Standardizing the summary and reporting of phase III safety data
  6. Standardizing the purity of data for submission
  7. The role of decision analysis in drug development
  8. Post-approval development in clinical trials / phase IV
  9. Sequential dose-finding strategies
  10. Monitoring ongoing trials (predictive probabilities, etc.)
  11. Study selection in the setting of limited patient resources and global priorities / Which study to run?
  12. Using hybrid phase transitions / Whither phases I, II, and III?

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