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:

    • Session Slides:

    • Lecture 1 Slides (revised 1/9/2020) 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.

    • Abstract & Video: Schwalm, Jon-David, et al. "A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial." The Lancet 394.10205 (2019): 1231-1242. URL
      Not available unless: Your ID number contains 02

    • Optional Reading:

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

    • Li, Bai, et al. "The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial." PLoS medicine 16.11 (2019). File
      Not available unless: Your ID number contains 02

    • Assignment:

              1) Email your research question(s) to your section leader on Friday, January 10, 2020 by 5pm.

              2) Complete homework assignment #1 and submit to TAs by Monday, January 13, 2020, 5pm at UCSFClinicalTrials2020@gmail.com

              3) Work on protocol assignment #1 and submit to your section leader by Tuesday, January 21, 2020, 12pm. Please scroll down to section 1 (January 23, 2020) for sample protocols.

    • Homework Assignment for Lecture 1 File
    • Protocol Assignment #1 File

    • Assignment Due Date: 

      Friday, 1/10/2020: Research Question due to Section Leaders

      Monday, 1/13/2020, 5pm: Lecture 1 Homework Assignment due to TAs. Email homework to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

      Tuesday, 1/21/2020, 12pm: Protocol Assignment #1 due to section leaders. Email protocol assignments to Section Leaders.


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