Section outline

  • Lecture 9: 

    Lecture 9A (Black):  Can a surrogate measurement substitute for a clinical endpoint? Don Quixote vs. the windmill (FDA). 

    Lecture 9B (Boxer): Clinical trials for Alzheimer’s disease and related dementias

    Faculty:  Dennis Black & Adam Boxer


    • Session Slides:

    • Boxer: Alzheimer's Clinical Trials File
      Not available unless: You belong to a group in Registered Students Only
    • Black: Surrogate Endpoint File
      Not available unless: You belong to a group in Registered Students Only

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

    • Boxer: Alzheimer's clinical trials Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Black: Surrogate Endpoints Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Recorded lecture should be viewed prior to this session.

      Workshop: Dr. Boxer will present "The sad and lamentable story of a drug called Aduhelm: a tragedy from multiple perspectives"

      Meeting ID: 955 5325 5749; Password: 655637
      https://ucsf.zoom.us/j/95553255749?pwd=R2N0aVdsZzFONzdmQ1JBWHpmRTF5dz09&from=addon

    • Aducanumab Workshop File
      Not available unless: You belong to a group in Registered Students Only
    • Aducanumab Workshop Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

    • Comments for readings - README File
    • Black DM, et al. "Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: metaregression analyses of individual patient data from multiple randomised controlled trials". Lance Diab Endocrinol 2020. File
      Not available unless: You belong to a group in Registered Students Only
    • Surrogate endpoints table from FDA website File
      Not available unless: You belong to a group in Registered Students Only
    • Dunn B. "Approval of Aducanumab for Alzheimer Disease— The FDA’s Perspective". JAMA 2021 File
      Not available unless: You belong to a group in Registered Students Only

    • Optional Reading:

    • Assignments and Due Date:

      1. Homework: There is no homework assignment for this week (updated as of 2/28/22).

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