Section outline

  • Lecture: Measuring Outcomes and Adverse Effects

    Defining adverse events; elicited vs. volunteered; nuisance adverse events; pitfalls of attribution of cause; FDA adverse events classifications.

    Faculty:  Steve Cummings

    Location:  China Basin 6702

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

      No lecture recording this week

    • 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
    • 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

    • Assignment:

      Exercises from Lecture 4 are due Monday, February 10, 2014 by 5pm: email to C. Seib and J. Valdez at clinicaltrials2014@gmail.com. Bring a copy to Section II.

      Email your cumulative protocol to your Section Leader by 12pm (noon) on Monday, February 10, 2014; bring a copy to Section II.

      Protocol Assignment due for Section II:

      Continue to revise the protocol sections developed for Section I. Add the following sections (4 pages total max):

      1. Control group(s)

      2. Intervention(s)

      3. Methods for randomization and blinding

      4. Methods for maximizing adherence

    • AssignL4 2014 File

    • Assignment Due Date:  

      Cumulative protocols due to your Section Leader by 12pm (noon) on Monday, February 10, 2014

      Exercises from Lecture 4 are due Monday, February 10, 2014 by 5pm

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