Section outline

  • Lecture: Design, Subjects and Randomization

    Definition and importance of randomized controlled trials (RCT); examples of RCTs; disadvantages; alternatives; reasons for doing RCTs; randomization; inclusion/exclusion criteria; study designs including classical RCT, factorial designs, cross-over designs, matched pairs, cluster or grouped randomization.

    Faculty:  Dennis Black

    Location:      Mission Hall 1400

    • Prospectus:

    • 2019CTCoursePlan 12.27.2018 File

    • Session Slides:

    • CT Lecture 1 File

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

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 142-147 and Chapter 11, pages 151-158.

    • Lippman S, et al. Effect of selenium and vitamin E on risk of prostate cancer and other cancers. JAMA. 2009;301(1):(doi:10.1001/jama.2008.864) [Note: read abstract and comment sections, review the tables and figures and skim the rest] 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
    • Black DM, et al. PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003:349:1207-15. [Note: read abstract] File
      Not available unless: Your ID number contains 02
    • Section from PaTH Protocol File
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapters 4, 5, and 6.

    • Assignment:

              1) Email your research question(s) to your section leader on Friday, January 11, 2019 by 5pm.

              2) Complete homework assignment #1 and submit to TAs by Monday, January 14, 2019, 5pm at UCSFClinicalTrials2019@gmail.com

              3) Work on protocol assignment #1 and submit to your section leader by Tuesday, January 22, 2019, 12pm. Please scroll down to section 1 (January 24, 2019) for sample protocols.

    • AssignL1 2019 File
    • Protocol Assignment 1 File

    • Assignment Due Date: 

      Exercises from Lecture 1 are due Monday, January 14, 2019 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2019@gmail.com

      Protocol assignment #1 due to section leaders on Tuesday, January 22, 2019 at 12pm. 

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