Section outline

  • Lecture 4: Statistical Issues in Randomized Trials, Review of data analysis for RCTs; Factorial RCT designs and analysis approaches; Subgroups and multiple comparisons: implications for inference from RCTs. Also most informative statistical graphic techniques for RCTs. 

    Pervasiveness of multiple comparisons in randomized trials; the general problem of multiple comparisons and statistical adjustments; multiple endpoints; statistical concerns about subgroup analyses; what to do with an unexpected subgroup finding; adverse experience categorization; multivariate adjustment.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL


    • Lecture Recording (watch prior to Thursday):

    • Lecture 4A Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 4B Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 4A File
      Not available unless: You belong to Registered Students Only
    • Lecture 4B File
      Not available unless: You belong to Registered Students Only

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

    • Live Large Group Session (Access restricted to registered students): NO LIVE SESSION THIS WEEK

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 164-166

    • Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine--reporting of subgroup analyses in clinical trials. N Engl J Med. 2007 Nov 22;357(21):2189-94. File
      Note: this paper sets the standard for evaluating RCT subgroup analyses.
      Not available unless: Your ID number contains 02
    • Polack, Fernando P., et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." N Engl J Med (2020) File
      Not available unless: Your ID number contains 02
    • Lippman S, et al. Effect of selenium and vitamin E of risk on prostate cancer and other cancers. JAMA. 2009;301(1):(doi:10.1001/jama.2008.864) File
      Not available unless: Your ID number contains 02
    • Gaziano J, et al. Vitamins E and C in the prevention of prostate and total cancer in men: The Physicians' Health Study II randomized controlled trial. JAMA 2009;301(1):(doi:10.1001/jama.2008.862 File
      Not available unless: Your ID number contains 02
    • Manson et al. Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease. NEJM 2019 File

      Read and review the abstract

      Not available unless: Your ID number contains 02
    • Manson et al. Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer NEJM 2019 File

      Read and review the abstract

      Not available unless: Your ID number contains 02

    • Assignment & Due Dates for this week:

      1.  Homework: Complete homework assignment for lecture #4 and submit to TAs by Monday, February 1, 2021, 5pm at UCSFClinicalTrials2021@gmail.com
      2.  Protocol: Continue working on protocol assignment #2 and submit to your section leader by Thursday, February 4, 2021; 12pm. 


    • Homework Assignment #4 File
      Not available unless: You belong to Registered Students Only
    • Lecture 4 Homework Assignment Answer Key File
      Not available unless: You belong to Registered Students Only