Section outline

  • Lecture: 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 RCT

    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:  Mission Hall 1400

    • Session Slides:

    • stat issues L3 2020 db 1-29 File

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

    • 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
      Not available unless: Your ID number contains 02

    • Please read/review the abstracts from the following 2 papers. For this lecture, review how statistical issues for multiple treatments, multiple outcomes and subgroups were handled.

    • 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
      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
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapter 17

    • Assignment: Lecture 3 homework assignment is due on Monday, February 3, 2020 at 5pm. Email homework assignment to TAs: UCSFClinicalTrials2020@gmail.com

    • AssignL3_2020 File
      Not available unless: Your ID number contains 02