Section outline

  • Lecture 5: 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 (Access restricted to registered students): Zoom URL

    • Session Slides:

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

    • Lecture 5 Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 5 File
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    • Lecture 5B: Sample Size Media Resource
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    • Lecture 5B: Sample Size File
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    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      Workshop 4: This live interactive session will focus on case studies of follow-up and adherence challenges

    • Workshop 4 Media Resource
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    • Workshop 4 File
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    • Required Reading:

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

    • 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 and Due Dates

      1. Homework: Complete homework assignment for lecture #5 and submit to TAs by Monday, February 7, 2022, 5pm at UCSFClinicalTrials2022@gmail.com

    • Homework Assignment for Lecture 5 File
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    • Assignment Answer Key (Access restricted to registered students):

    • Lecture 5 Homework Assignment Answer Key File