Section outline

  • Lecture: Design, Subjects and Randomization

    Definition and importance of randomized controlled trials (RCT); examples of RCTs; disadvantages; alternatives; reasons for doing RCTs; randomization; inclusion/exclusion criteria; study designs including classical RCT, factorial designs, cross-over designs, matched pairs, cluster or grouped randomization.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL

    • Prospectus:

    • Lecture Videos (watch prior to Thursday): 

    • Epi205 Course Logistics Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Epi205 2022 Course Logistics File
    • Lecture 1A Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1A File
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1B Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1b File
      Not available unless: You belong to Registered Students Only

    • 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 1:  This live/Zoom session will focus on challenges in interpretation of trial results related to participant inclusion/exclusion (topic in lecture 1) using examples from one of the Remdesivir Covid trials as well as other Covid trials.  The session will also include a brief review and time for Q&A about lecture and course logistics.

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

    • Workshop 1_Black Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • EUA Review_Pfizer File
      Not available unless: You belong to a group in Registered Students Only
    • FDA Fact Sheet_Paxlovid File
      Not available unless: You belong to a group in Registered Students Only
    • Ethics_Paxlovid File
      Not available unless: You belong to a group in Registered Students Only
    • Molnupiravir_Bernal NEJM File
      Not available unless: You belong to a group in Registered Students Only
    • Molnupiravir_Dyer BMJ File
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 142-147 and Chapter 11, pages 151-158.

    • Baden et al. "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine" N Engl J Med (2020) File
      Not available unless: You belong to a group in Registered Students Only
    • Baden et al. “Research Summary: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine” N Engl J Med 2020 File
      Not available unless: You belong to a group in Registered Students Only
    • MODERNA Protocol File

      MODERNA Protocol: Scan the Moderna trial protocol summary and read the following sections within the summary:

      • Randomization
      • Inclusion & Exclusion

      Not available unless: You belong to Registered Students Only
    • Abstract & Video: Schwalm, Jon-David, et al. "A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial." The Lancet 394.10205 (2019): 1231-1242. URL

      Read abstract and watch a 3 min video abstract of a cluster randomized, international study. Schwalm et al. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet, 2019 Oct 5;394(10205):1231-1242  

      Not available unless: You belong to Registered Students Only

    • Optional Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapters 4, 5, and 6.

    • Manson et al., "Vitamin D supplements and prevention of cancer and cardiovascular disease" NEJM 380.1 (2019): 33-44 File
      Not available unless: You belong to a group in Registered Students Only
    • Li, Bai, et al. "The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial." PLoS medicine 16.11 (2019). File
      Not available unless: You belong to a group in Registered Students Only

    • Assignment & Due Dates for this week:

              1) Research Question: Email your research question(s) to your section leader on Friday, January 7, 2022 by 5pm.

              2) Homework: Complete homework assignment #1 and submit to TAs by Monday, January 10, 2022, 5pm at UCSFClinicalTrials2022@gmail.com

              3) Protocol: Work on protocol assignment #1 and submit to your section leader by Tuesday, January 18, 2022, 12pm. Please scroll above for sample protocols.

    • Homework Assignment #1 File
      Not available unless: You belong to a group in Registered Students Only
    • Biegel et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med 2020 File

      This article will be referred to in the homework.

      Not available unless: You belong to a group in Registered Students Only

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

    • Answer Key for Assignment #1 File