Section outline

  • Lecture 3: Measuring Outcomes and Adverse Effects

    Clinical outcomes and alternatives. Defining adverse events; elicited vs. volunteered; nuisance adverse events; pitfalls of attribution of cause; FDA adverse events classifications.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL


    • Session Slides:

    • Lecture 3a_2022 File
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 3b_2022 File
      Not available unless: You belong to a group in Registered Students Only

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

    • Lecture 3A_2022 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 3b_2022 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 - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      Workshop 3: In this interactive, live/zoom discussion session we will focus on quandaries and controversies about efficacy and safety outcomes related to Covid-19 trials

    • Workshop 3 File
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 140-142, Chapter 11 page 162

    • Psaty BM, Lumley T. Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs. JAMA. 2008 Mar 26;299(12):1474-6. File
      Not available unless: Your ID number contains 02
    • Bent S, et al. Brief communication: Better ways to question patients about adverse medical events: a randomized, controlled trial. Ann Intern Med. 2006 Feb 21;144(4):257-61. File
      Not available unless: Your ID number contains 02
    • Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. PMID: 33306990. File

      Please read this article prior to Thursday's workshop

      Not available unless: You belong to Registered Students Only
    • Voysey M, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. File

      Please read this article prior to Thursday's workshop

      Not available unless: You belong to Registered Students Only

    • Homework Assignment: Exercises from Lecture 3 are due Monday, January 24, 2022 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2022@gmail.com.  Bring a copy to Section.

    • Homework Assignment for Lecture 3 File
      Not available unless: You belong to Registered Students Only

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

    • Homework Assignment for Lecture 3 - Answer Key File