Learning : Short Courses

 
 


The Design and Monitoring of Group Sequential Clinical Trials

Daniel L. Gillen, PhD and John M. Kittelson, PhD

August, 2013

Abstract: In this module we provide an introduction to methodology for the design, monitoring and analysis of group sequential trials. The module will present and illustrate methods for adaptive trial design that maintain pre-specified trial operating characteristics. Methodology will be presented using case studies and examples of clinical trials with continuous, binary, and survival endpoints. The sequential methods will be illustrated using RCTdesign, an R module for the design, monitoring, and analysis of clinical trials. Emphasis will be placed on both the scientific and statistical impact of group sequential trial design.


  1. •Session 1 - Introduction

  2. •Session 2 - Fixed Sample Trial Design

  3. •Session 3 - Introduction and Evaluation of Group Sequential Designs

  1. •Session 4 - Bayesian Evaluation of Group Sequential Designs

  2. •Session 5 - Monitoring Group Sequential Trials

  3. •Session 6 - Inference Following Group Sequential Tests


  1. •Session 7 - Special Considerations: Futility and Non-Inferiority Decisions

  2. •(FDA Guidance for Non-Inferiority RCT)

  3. •Session 8 - Special Considerations: Nonproportional Hazards Survival Data

Course Handouts (pdf):


Learning Material:


  1. •Short Courses

  2. •Research Talks

  3. •Case Studies


  1. •Session 1 Code

  2. •Session 2 Code

  3. •Session 3 Code - Lecture Results

  4. •Session 3 Code - Case Study

  1. •Session 4 Code

  2. •Session 5 Code

  3. •Session 7 Code



R Code to Produce the Results in Each Handout:

  1. •Session 2 In-class Exercises                  (R code) (Solutions)

  2. •Session 2 Take-home Exercises             (R code) (Solutions)                                   

  1. •Session 3 In-class Exercises                   (R code) (Solutions)

  2. •Session 3 Take-home Exercises              (R code) (Solutions)


  1. •Session 4 Exercises                               (R code) (Solutions)

  2. •Session 5 Exercises                                (R code) (Solutions)

Course Exercises and R Code Solutions: