Ben Goldacre (previously) led a team that created the FDAAA Trials Tracker, "A live informatics tool to monitor compliance with FDA requirements to report clinical trial results."
Goldacre has spent years campaigning to force companies to report in all their clinical trials; many of the drugs on the market today were approved even though more than half of their trials never reported in, meaning that pharma companies were able to cherry-pick the trials that yielded favorable results and simply not publish trials that showed that their products were useless or even harmful.
The US government currently requires all trials to be registered on ClinicalTrials.gov when they start — trials that aren't reported in at their commencement are not eligible for consideration during FDA evaluation; and since ClinicalTrials.gov is public, it should be possible for the public and watchdogs to discover whether pharma companies are reporting in on all their trials.
That's where FDAAA Trials Tracker comes in: it downloads an XML dump from ClinicalTrials.gov, analyzes it, and tracks which trials are due or overdue, as well as "whether they have reported results in accor-
dance with the law; give performance statistics
for each individual trial sponsor; and calculate
potential fines that could have been levied by
the FDA against sponsors."
Past work has shown that results from trials
often go unreported, despite numerous guidelines, commitments and legal frameworks intended to ensure complete reporting. Without
formal sanctions being imposed by the FDA
and others, we believe that open data tools that
provide public accountability have a valuable
role in improving standards.
Specifically, we hope that the presence of easily accessible public data, and rankings, show-
ing how individual sponsors are meeting their
obligations, may encourage organisations to
prioritise results reporting in general. In particular, the dynamic nature of the data presented
through our tools incentivises organisations to
report their trial results, because – unlike in a
static academic publication on trial reporting –
they can immediately improve their public rating, by reporting their results. In addition, the
online resources we have produced here and
elsewhere make it extremely easy for sponsors
to identify individual trials from their organisations which have not yet reported their results:
our tools therefore offer positive practical support for those sponsors who wish to ensure
that all their completed trials have reported
results.
FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results [Nicholas J. DeVito, Seb Bacon, and Ben Goldacre/Biorxiv]
