Section outline

  • Lecture: Statistical Issues in Randomized Trials

    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 2017 final 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

    • The following 2 articles were read for Lecture 1.  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

    • Optional Reading:

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

    • Assignment: There is no homework assignment for Lecture 3