Compliance with results reporting at ClinicalTrials.gov.

ABSTRACT:

Background

The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.

Methods

Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated wit

SUBMITTER: Anderson ML 

PROVIDER: S-EPMC4508873 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature