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 conduct the generalizability assessment 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.

Learning Objective 1: After attending this session, the learners will be able to:

Use GIST metric to assess the a priori generalizability of clinical trials on a certain disease domain
Compare the a priori and a posteriori generalizability assessment on clinical trials


Zhe He (Presenter)
Florida State University

Arturo Gonzalez-Izquierdo, University of College London
Spiros Denaxas, University of College London
Andrei Sura, University of Florida
Yi Guo, University of Florida
William Hogan, University of Florida
Elizabeth Shenkman, University of Florida
Jiang Bian, University of Florida

Presentation Materials: