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Publication Detail
Comparing and Contrasting A Priori and A Posteriori Generalizability Assessment of Clinical Trials on Type 2 Diabetes Mellitus
  • Publication Type:
  • Authors:
    Zhe H, Gonzalez-Izquierdo A, Denaxas SC, Sura A, Guo Y, Hogan W, Shenkman E, Bian J
  • Publisher:
    Hanley and Belfus, Inc.
  • Publication date:
  • Published proceedings:
    Proceedings - a conference of the American Medical Informatics Association / . AMIA Annual Fall Symposium. AMIA Fall Symposium
  • Name of conference:
    American Medical Informatics Association / . AMIA Annual Fall Symposium
  • Conference place:
    Washington DC, USA
  • Print ISSN:
Clinical trials are indispensable tools for evidence-based medicine. However, they are often criticized for poor generalizability. Traditional trial generalizability assessment can only be done after the trial results are published, which compares the enrolled patients with a convenience sample of real-world patients. However, the proliferation of electronic data in clinical trial registries and clinical data warehouses offer a great opportunity to assess the generalizability during the design phase of a new trial. In this work, we compared and contrasted a priori (based on eligibility criteria) and a posteriori (based on enrolled patients) generalizability of Type 2 diabetes clinical trials. Further, we showed that comparing the study population selected by the clinical trial eligibility criteria to the real- world patient population is a good indicator of the generalizability of trials. Our findings demonstrate that the a priori generalizability of a trial is comparable to its a posteriori generalizability in identifying restrictive quantitative eligibility criteria.
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