RT Journal Article
SR Electronic
T1 FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results
JF bioRxiv
FD Cold Spring Harbor Laboratory
SP 266452
DO 10.1101/266452
A1 DeVito, Nicholas J.
A1 Bacon, Seb
A1 Goldacre, Ben
YR 2018
UL http://biorxiv.org/content/early/2018/03/12/266452.abstract
AB Introduction Non-publication of clinical trials results is an ongoing issue. The US government recently updated the requirements on results reporting for trials registered at ClinicalTrials.gov. We set out to develop and deliver an online tool which publicly monitors compliance with these reporting requirements, facilitates open public audit, and promotes accountability.Methods We conducted a review of the relevant legislation to extract the requirements on reporting results. Specific areas of the statutes were operationalized in code based on the results of our policy review, and on the publicly available data from ClinicalTrials.gov. We developed methods to identify trials required to report results, using publicly accessible data; to download additional relevant information such as key dates and trial sponsors; and to determine when each trial became due. This data was then used to construct a live tracking website.Results There were a number of administrative and technical hurdles to successful operationalization in our tracker. Decisions and assumptions related to overcoming these issues are detailed along with clarifying details from outreach directly to ClinicalTrials.gov. The FDAAA TrialsTracker was successfully launched and provides users with an overview of results reporting compliance.Discussion Clinical trials continue to go unreported despite numerous guidelines, commitments and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours providing live data on trial reporting - can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.