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:  Dennis Black

    Location:  Mission Hall 1400

    • Session Slides:

    • outcomes and events vers 2-8-19 final File

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

    • 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
    • Miller, PD., et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis a randomized clinical trial. Jama 316.7 (2016) 722-733. File
      Not available unless: Your ID number contains 02
    • Black, DM., et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. New England Journal of Medicine 356.18 (2007) 1809-1822. File
      Not available unless: Your ID number contains 02

    • Homework Assignment: Exercises from Lecture 4 are due Monday, February 11, 2019 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2019@gmail.com.  Bring a copy to Section II.

      Protocol Assignment due for Section II: Email your cumulative protocol to your Section Leader by 12pm (noon) on Monday, February 11, 2019; bring a copy to Section II.

      Continue to revise the protocol sections developed for Section I. Please see protocol assignment #2 for instructions.

    • AssignL4 2019 File
    • Protocol Assignment 2 File

    • Assignment Due Date:  

      Protocol assignment #2 is due Monday, February 11, 2019 by 12pm; email to Section Leader.

      Homework exercises from Lecture 4 are due Monday, February 11, 2019 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2019@gmail.com.

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