Section outline

  • Lecture 8:  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:

    • Trial Ethics & Interim Monitoring File
      Not available unless: You belong to Registered Students Only
    • Biostatistical Methods for Monitoring RCTs File
      Not available unless: You belong to Registered Students Only

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

    • Trial Ethics & Interim Monitoring Media Resource
      Not available unless: You belong to Registered Students Only
    • Biostatistical Methods for Monitoring RCT Media Resource
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 9:45 am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      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.

    • Live Session: Interim Monitoring (Huang) Media Resource
      Not available unless: You belong to Registered Students Only
    • Live Session: Interim Monitoring (Huang) File
      Not available unless: You belong to 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 #8 is due March 1, 2021; 5pm. Email assignment to Teaching Assistants (ucsfclinicaltrials2021@gmail.com)

    • Lecture 8 Homework File
      Not available unless: You belong to Registered Students Only

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

    • Lecture 8 Homework Assignment - Answer Key File
      Not available unless: You belong to Registered Students Only