Title
Assessing the Validity of a a priori Patient-Trial Generalizability Score using Real-world Data from a Large Clinical Data Research Network - A Colorectal Cancer Clinical Trial Case Study.
Abstract
Existing trials had not taken enough consideration of their population representativeness, which can lower the effectiveness when the treatment is applied in real-world clinical practice. We analyzed the eligibility criteria of Bevacizumab colorectal cancer treatment trials, assessed their a priori generalizability, and examined how it affects patient outcomes when applied in real-world clinical settings. To do so, we extracted patient-level data from a large collection of electronic health records (EHRs) from the OneFlorida consortium. We built a zero-inflated negative binomial model using a composite patient-trial generalizability (cPTG) score to predict patients' clinical outcomes (i.e., number of serious adverse events, [SAEs]). Our study results provide a body of evidence that 1) the cPTG scores can predict patient outcomes; and 2) patients who are more similar to the study population in the trials that were used to develop the treatment will have a significantly lower possibility to experience serious adverse events.
Year
Venue
DocType
2019
AMIA
Conference
Volume
ISSN
Citations 
2019
1942-597X
0
PageRank 
References 
Authors
0.34
0
8
Name
Order
Citations
PageRank
Li Qian100.34
Zhe He26319.17
Yi Guo31210.16
Zhang Hansi400.34
Thomas J. George552.55
William R. Hogan629453.52
Neil Charness719129.98
Jiang Bian815043.09