The representativeness of eligible patients in type 2 diabetes trials: a case study using GIST 2.0.

ABSTRACT:

Objective

The population representativeness of a clinical study is influenced by how real-world patients qualify for the study. We analyze the representativeness of eligible patients for multiple type 2 diabetes trials and the relationship between representativeness and other trial characteristics.

Methods

Sixty-nine study traits available in the electronic health record data for 2034 patients with type 2 diabetes were used to profile the target patients for type 2 diabetes trials. A set of 1691 type 2 diabetes trials was identified from ClinicalTrials.gov, and their population representativeness was calculated using the published Generalizability Index of Study Traits 2.0 metric. The relationships between population representativeness and number of traits and between trial

SUBMITTER: Sen A 

PROVIDER: S-EPMC7378875 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature