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In this lesson, among other things, we learned:

  • Differentiate between valid and invalid reasons for interim analyses and early termination of a trial.
  • Identify characteristics of a sound plan for interim analysis.
  • Understand the theoretical framework for a likelihood based interim analysis.
  • Compare and contrast the Bayesian approach to analysis with the frequentist approach.
  • Recognize the general effects of the choice the prior on the posterior probability distribution from a Bayesian analysis.
  • Compare α spending functions for 3 group sequential methods for interim analysis.
  • Comment on the use of a group sequential method in a published statistical analysis.
  • Recognize a futility assessment and define conditional power.
  • List topics that should be covered in an interim report to an IRB.
  • List the advantages and disadvantages of a DSMB and describe who might compose the DSMB.
  • List the issues of concern to a DSMB in a typical clinical study.