Section outline

  • Lecture: Follow-up, Adherence to the Protocol, and Post-Randomization and Introduction to Sample Size Planning

    Follow-up in RCTs; what happens after randomization; patient compliance or adherence; effect of incomplete follow-up; strategies to enhance compliance; intention-to- treat and per-protocol analyses; analysis based on post-randomization; subgroup analysis.

    Faculty:  Dennis Black

    Location:      Mission Hall 1400

    • Session Slides:

    • RCT course follow up 2018 File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 6, pages 55-59 and Chapter 11, pages 160-162.

      Fundamentals of Clinical Trials (4th Edition), Chapter 14.

    • Hollis and Campbell. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ 1999:319;670-4. File
      Not available unless: Your ID number contains 02

    • Assignment:

      Exercises from Lecture 5 are due February 26, 2018 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2018@gmail.com

    • AssignL5_2018 Assignment

    • Assignment Due Date:  February 26, 2018 by 5pm

    • Assignment Answer Key (Access restricted to registered students):