%0 Journal Article
%T Comparing and Contrasting A Priori and A Posteriori Generalizability Assessment of Clinical Trials on Type 2 Diabetes Mellitus
%A Andrei Sura
%A Arturo Gonzalez-Izquierdo
%A Elizabeth Shenkman
%A Jiang Bian
%A Spiros Denaxas
%A William R. Hogan
%A Yi Guo
%A Zhe He
%J Archive of "AMIA Annual Symposium Proceedings".
%D 2017
%X 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
%U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977671/