Learning : Short Courses

 
 
  1. We at RCTdesign.org regularly present short courses on the design, monitoring, and reporting of group sequential clinical trials as well as special research topics such as adaptive methods for trial monitoring.  These courses all use RCTdesign software as the means to implement the discussed methodology. Below are links to slides from these courses.  In some cases, recorded slide shows with the accompanying audio are also provided.


Jun, 2024: Design, Conduct, and Analysis of Randomized Clinical Trials with Time to Event Primary Endpoints
This is a short course originally delivered as a Module in the Summer Institute in Statistics for Clinical and Epidemiologic Research (SISCER) sponsored by the University of Washington Department of Biostatistics. The analysis of data measuring time to event is often complicated by incomplete observations: Some subjects have not yet had an event at the time of data analysis. A wide variety of statistical methods have been developed for use in this setting of “right censored data”, including parametric and semiparametric regression models, as well as a broad array of nonparametric methods. The common problems that arise in the clinical trial settings interact with the statistical behavior of the analysis methods in such a way as to warrant special attention. Most of the course consisted of pre-recorded lectures. Three synchronous discussion sections were also held and recorded.


March, 2010: Adaptive Randomization in Phase III Clinical Trials
This is a half-day short course originally delivered to an audience of statistical researchers. The course presents an overview of randomization strategies for clinical trials, with an emphasis on covariate adaptive allocation of patients to treatment arms. Response adaptive modification of randomization ratios is also covered.

November, 2010: Adaptive Clinical Trials
This is a one-day short course originally delivered to an audience of statistical reviewers in a regulatory environment. The course presents an overview of group sequential and adaptive clinical trial designs.

August, 2012, 2013: The Design and Monitoring of Group Sequential Clinical Trials
This is a three-day short course originally delivered at the Summer Institute in Biostatistics at the University of Washington. The first day of the course is primarily directed toward the scientific design of a randomized clinical trial and the design of fixed sample trials. The second day then considers the evaluation of group sequential designs (Frequentist and Bayesian) as well as strategies for monitoring trials.  The final day considers inference following the completion of a trial and special topics including non-inferiority designs and special considerations for time-varying treatment effects.  All examples in the course are carried out using RCTdesign.


January, 2014: Adaptive Clinical Trials and Screening Trials
This is a 1.5 hour lecture that is an extended version of a talk given to at the Accelerating Anti-cancer Agent Development and Validation Workshop in May, 2011. The course presents an overview of the use of group sequential and adaptive clinical trial designs in phase 2 trials.


June 2014: Data Monitoring Committees (DMC)
This is a one-day short course originally delivered at the Summer Institute for Statistics in Clinical Research (SISCR) sponsored by the Department of Biostatistics at the University of Washington. The first part of the course gives an overview of DMCs in the monitoring of a randomized clinical trial. The second part focuses on the role of a statistician who is either responsible for providing data analyses to a DMC or serving as the DMC member statistician.


June, 2014: Introduction to the Design and Evaluation of Adaptive Group Sequential Clinical Trials
This is a one-day short course originally delivered at the Summer Institute in Biostatistics at the University of Washington. The course is primarily directed toward the scientific design of a randomized clinical trial and the evaluation of group sequential designs (Frequentist and Bayesian).