Section outline

  • Lecture 7:  Nuts and Bolts  - Conducting a Trial

    Should one do a trial; pilot studies; funding sources; contracts; budgets; the study team; team management; space; recruitment of study subjects; starting the protocol; forms; compliance and follow-up; final visit and post-trial.

    Faculty:  Deborah Grady & Steven Cummings


    • Session Slides:

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

    • Lecture Update: Please use Dr. Grady's 2019 lecture & slides "Nuts & Bolts"

    • Pilot Studies and Nuts&Bolts File
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In live/Zoom session, Dr. Steven Cummings will lead an interactive session focusing on the use of new technologies to perform “Trials from home”: trials without clinical centers. This is fundamentally changing the way trials can be done.

    • NY Times Article: Clinical Trials Are Moving Out of the Lab and Into People’s Homes File
      Not available unless: You belong to Registered Students Only
    • Workshop: Dr. Cummings - Remote Trials Media Resource
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 158-159 and Chapter 17.

    • Assignments and Due Dates: 

      1. Homework: There is no homework assignment for Lecture 7.
      2. Protocol: Continue working on protocol assignment #3. Send the protocol assignment to your section leader by Thursday, February 18, 2021; 12pm.