Technical Reports : General Methods for RCT


Sample Size Estimation in the Proportional Hazards Model for K-sample or Regression Settings

  1. Summary:  A technical document describing the use of the general formula for sample size estimation in a broad variety of RCT settings, with particular emphasis on the proportional hazards model.

  2. Ref: Emerson SS (2005)

Evaluation of Strategies for the Phase II to Phase III Progression in Treatment Discovery

  1. Summary:  Brittany J. Sanchez Thesis: An investigation of the importance of well-planned progression from Phase II to Phase III RCT in order to ensure a sufficiently low false positive rate of adopting ineffective treatments (a low type 1 error), a sufficiently high probability of adopting truly effective treatments (a high statistical power), and a sufficiently high probability that adopted treatments will be truly effective (a high positive predictive value). Also investigated in the bias associated with early termination of group sequential RCT.

  2. Ref: Sanchez BJ (2014)