Learning : Short Courses

 
 


2024 SISCER Module 3:
Design, Conduct, and Analysis of Randomized Clinical Trials
with Time to Event Primary Endpoints

Scott S. Emerson, MD, PhD

July, 2024

Abstract: 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.


  

Video Recordings (mp4) and slide handout (pdf):  

  1. •0. Course Overview (10:07) (mp4) (pdf)


  1. •1. Drug Discovery (29:16) (mp4) (pdf)


  1. •2. Clinical Estimands (38:59) (mp4) (pdf)


  1. •3. RCT Estimands (16:32) (mp4) (pdf)


  1. •4. ICH E9 (R1) (31:22) (mp4) (pdf)


  1. •5. Time to Event (60:00) (mp4) (pdf)


  1. •6. Summary Measures (13:53) (mp4) (pdf)


  1. •7. Hazards, CDF (27:23) (mp4) (pdf)


  1. •8. Survival descriptives (22:22) (mp4) (pdf)


  1. •9. Survival estimation (25:24) (mp4) (pdf)


  1. •10. Parametric infrnc (24:44) (mp4) (pdf)


  1. •11. Semiparam infrnc (48:14) (mp4) (pdf)


  1. •12. Distn free infrnc (63:35) (mp4) (pdf)


  1. •13. Overview of RCT (11:10) (mp4) (pdf)


  1. •14. Screening Trials (74:53) (mp4) (pdf)


  1. •15. Precision (24:17) (mp4) (pdf)


  1. •16. Adjusted Analyses (77:28) (mp4) (pdf)


  1. •17. Randomization (80:49) (mp4) (pdf)


  1. •18. Sample Size (19:32) (mp4) (pdf)


  1. •19. Intro to GSD (26:57) (mp4) (pdf)


  1. •20. GS Boundaries (42:40) (mp4) (pdf)


  1. •21. RCTdesign (15:08) (mp4) (pdf)


  1. •22. Evaluation (35:28) (mp4) (pdf)


  1. •23. Case Study (37:49) (mp4) (pdf)


  1. •24. Sensitivity (20:19) (mp4) (pdf)


  1. •25. Protopathic Bias (79:57) (mp4) (pdf)


  1. •26. Noninferiority (105:56) (mp4) (pdf)


  1. •27. Inference (00:00) (mp4) (pdf)


  1. •28. Adaptive (102:29) (mp4) (pdf)


  1. •29. tba (00:00) (mp4) (pdf)



Learning Material:


  1. •Intro to Statistics

  2. •Short Courses

  3. •Research Talks

  4. •Case Studies