Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

ABSTRACT: Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified char

SUBMITTER: Riley IL 

PROVIDER: S-EPMC6007020 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature