Section outline

  • Lecture:  Ethics in Clinical Trials and 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

    Location:     Mission Hall 1400

    • Session Slides:

    • Trial Ethics and Interim Monitoring 2019 3-7-19 File

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

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 163-164 and 168-169.

    • Lo B. Ethical issues in clinical trials, pages 1-7. File
      Not available unless: Your ID number contains 02
    • Dixon D, Freedman R et al.. Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clinical Trials 2006. Nov 3: 314-19. File
      Not available unless: Your ID number contains 02
    • Bryant J and Wolmark N. Letrozole after tamoxifen for breast cancer--what is the price of success? N Engl J Med. 2003 Nov 6;349(19):1855-7. File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • DeMets DL, Pocock SJ, Julian DG. The agonizing negative trend in monitoring of clinical trials. Lancet 1999:354:1983-88. File
      Not available unless: Your ID number contains 02

    • Homework Assignment: Exercises from Lecture 7 are due March 11, 2019 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2019@gmail.com

      Protocol Assignment: Email your cumulative protocol to your section leader by 12pm (noon) on March 18, 2019; bring a copy to section #3.

      Assignment due for Section III:

      Continue to develop and finalize sections of your protocol started in prior sections. Draft the following sections stated in protocol assignment #3

    • AssignL7 2019 File
    • Protocol Assignment 3 File
    • Sample Protocol 1 File
    • Sample Protocol 2 File
    • Sample Protocol 3 File

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