Section outline

  • Lecture 6: Non-Inferiority Trials
    Faculty:  Vinay Prasad

    Non inferiority trials are studies that seek to show a new treatment, compared to an established treatment, is no worse than by some amount. That amount is called the margin or delta.  Equivalence trials are subset of the non-inferiority design

     



    • Lecture Recording (must watch prior to Thursday)

    • Lecture 6 - Non-Inferiority Trials Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 6 - No-Inferiority Trials 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 this zoom/live session, Dr. Prasad will lead a discussion about the pitfalls of non-inferiority. Who defines the delta?  What happens if the older treatment is delivered sub-optimally?  Can a trial be non-inferior, but actually worse?  And, finally, what percentage of NI trials are non-inferior?

    • Required Reading

    • Kudo M et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 2018 Mar 24;391(10126):1163-1173. File
      Not available unless: You belong to Registered Students Only
    • Prasad V. Non-Inferiority Trials in Medicine: Practice Changing or a Self-Fulfilling Prophecy? J Gen Intern Med 2018 Jan;33(1):3-5. doi: 10.1007/s11606-017-4191-y. File
      Not available unless: You belong to Registered Students Only

    • Assignment & Due Dates

      1. Homework: There is no homework assignment for lecture 6.
      2. Protocol: Continue working on protocol assignment #3. Due to section leaders on Thursday, February 18, 2021; 12pm.