Section outline

  • Lecture:  Pharmacoepidemiology in Drug Development/Study Design

    • Experimental and Observational Studies
    • Descriptive Epidemiology – Estimating patient populations, characterizing natural history of disease
    • Defining the exposure, outcomes and covariates
    • Selecting the appropriate study design
    • Sources of systematic error
      • Selection Bias
      • Confounding
      • Misclassification

     

    Faculty:  Michael Kelsh

    Location:  Mission Hall 1407

    • Session Slides:

    • Lecture 2 File

    • Required Reading:

      “Study designs available for Pharmacoepidemiologic Studies”  in Textbook of Pharmacoepidemiology  pp. 30-39

      Rothman KJ  Six Persistent Research Misconceptions; J Gen Intern Med DOI: 10.1007/s11606-013-2755  2014

       

    • Avorn J. In Defense of Pharmacoepidemiology – Embracing the Yin and the Yang of Drug Research. NEJM-357-2219-2221, 2007 File
      Not available unless: Your ID number contains 02
    • Jick H, Garcia Rodriguez LA, Perez-Gutthan S. Principles of epidemiological research on adverse and beneficial drug effects. The Lancet - 352(9142)-1767-70, 1998 File
      Not available unless: Your ID number contains 02
    • Schneeweiss S. Developments in post-marketing comparative effectiveness research. Clinical Pharmacol Therapeutics -82(2)-143-156, 2007 File
      Not available unless: Your ID number contains 02
    • Maclure M, Fireman B, Nelson JC et al. When should case-only designs be used for safety monitoring of medical products. Pharmacoepidemiol Drug Saf. 21(S1)- 50–61, 2012 File
      Not available unless: Your ID number contains 02