Section outline

  • Lecture 7:  Ethics in Clinical Trials and Interim Monitoring & Statistical Aspects of Interim Monitoring 

    Ethical issues in clinical trials, including choice of interventions in control and intervention groups, randomization, selection of subjects, and interim analyses

    Why alter/stop a clinical trial early; who should decide to stop the trial; what parameters should be monitored and how often; what statistical methods should be used; statistical approaches

    Faculty:  Alison Huang & Joan Hilton


    • Session Slides:

    • Ethics & Interim Monitoring (Huang) File
      Not available unless: You belong to a group in Registered Students Only
    • Statistics for Interim Monitoring File
      Not available unless: You belong to a group in Registered Students Only

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

    • Ethics and Interim Monitoring (Huang) Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Statistics for Interim Monitoring Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15 am PT.  Recorded lecture should be viewed prior to this session.

      Workshop 6: In live/Zoom session, Dr. Huang will lead an interactive session about recent clinical trials that have raised special ethical issues or involved controversial early termination.

      Topic: Interactive Discussion - Clinical Trials Ethics and Interim Monitoring Cases

      Meeting ID: 967 9358 6558, Password: 135874

      https://ucsf.zoom.us/j/96793586558?pwd=M2d1WU1rcWFMLzNZaGgzTlZWZWRvdz09


    • Workshop_Huang Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

      Fundamentals of Clinical Trials (5th Edition):

      • Chapter 16 “Monitoring Committee Structure and Function” 
      • Chapter 17 “Statistical Methods Used in Interim Monitoring”

    • Lo B. Ethical issues in clinical trials, pages 1-7. File
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Data monitoring in clinical trials: a practical perspective, (2nd Edition), Chapter 9 “Determining When a Data Monitoring Committee is Needed”


    • Assignments and Due Dates

      1. Homework: Homework assignment from lecture #7 is due February 24, 2022; 5pm. Email assignment to Teaching Assistants (ucsfclinicaltrials2022@gmail.com)
    • Homework_L7 (revised as of 2/16/22) File
      Not available unless: You belong to a group in Registered Students Only

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

    • Answer Key for Homework Assignment L7 File