Comparing and Contrasting A Priori and A Posteriori Generalizability Assessment of Clinical Trials on Type 2 Diabetes Mellitus

AMIA Annu Symp Proc. 2018 Apr 16:2017:849-858. eCollection 2017.

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.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic*
  • Databases, Factual
  • Datasets as Topic
  • Diabetes Mellitus, Type 2*
  • Electronic Health Records
  • Evidence-Based Medicine
  • Female
  • Humans
  • Male
  • Patient Selection*
  • Registries*
  • United Kingdom
  • United States