Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

ABSTRACT:

Objective

To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials.

Methods

We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study

SUBMITTER: Ma H 

PROVIDER: S-EPMC4837034 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature