Zhe, H; Gonzalez-Izquierdo, A; Denaxas, SC; Sura, A; Guo, Y; Hogan, W; Shenkman, E; Zhe, H; Gonzalez-Izquierdo, A; Denaxas, SC; Sura, A; Guo, Y; Hogan, W; Shenkman, E; Bian, J; - view fewer (2017) Comparing and Contrasting A Priori and A Posteriori Generalizability Assessment of Clinical Trials on Type 2 Diabetes Mellitus. In: Sarkar, N, (ed.) American Medical Informatics Association (AMIA) 2017 Annual Symposium. Hanley and Belfus, Inc.

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Abstract

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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