Section outline

  • Lecture: Blinding, Intervention and Controls

    Definition and importance of blinding; strategies if the study can’t be blinded; strategies to evaluate blinding; considerations when choosing the intervention; multiple interventions; importance of the control or placebo; advantages and disadvantages of equivalence trials.

    Faculty: Deborah Grady

    Location:  Mission Hall 1400

    • Session Slides:

    • Blind + Inter 2019 File

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

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 147-149.
      Fundamentals of Clinical Trials (4th Edition), Chapter 7.

    • Noseworthy H, et al. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 1994 44: 16-20. File
      Not available unless: Your ID number contains 02
    • Kirkley A, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. File
      Not available unless: Your ID number contains 02

    • Assignment:

    • AssignL2 2019 File

    • Assignment Due Date: 

      Homework for lecture 2 is due on Tuesday, January 22, 2019 at 5pm. Please email to TAs at UCSFClinicalTrials2019@gmail.com

      Email your protocol assignment #1 to your Section Leader by 12pm (noon) on Tuesday , January 22, 2019; bring a copy to Section I.

      Protocol assignment due for Section I:
      Draft the following sections of a protocol for a randomized trial to address your own research question (2 pages max).
      1. Research question(s)
      2. Type of randomized trial design
      3. Subjects (target and accessible populations) and inclusion/exclusion criteria.
      4. Outcome measures

      You may summarize, but do not copy from other protocols.

            

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

    • AnswerAssignL2 2019 File