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)

 


Technical Report Topics:


  1. •Probability models

  2. •General RCT methods

  3. •Noninferiority trials

  4. •Stopping rules

  5. •Adaptive methods

  6. •Implementation

  7. •Frequentist inference

  8. •Bayesian methods

  9. •Survival outcomes

  10. •Longitudinal outcomes

  11. •Medical diagnosis

  12. •Missing data

  13. •Software