In this lesson, among other things, we learned:

• Differentiate between valid and invalid reasons for interim analyses and early termination of a trial.
• Identify the 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.