FDAAA TrialsTracker Milestones: 6 Months, >1200 trials, $500 Million in Fines

On February 19, 2018 we launched the FDAAA TrialsTracker, a tool that automatically monitors whether clinical trials are reporting their results to ClinicalTrials.gov in accordance with US law. We bring public accountability by ranking sponsors, and help researchers to comply with the law by showing them which of their trials are overdue. We also calculate the total fines the FDA could have imposed to date on non-compliers.

This week marks two important milestones for the FDAAA TrialsTracker. Firstly, it’s six months since we first launched (and 6 months since the first trials came due under the “Final Rule” of the FDA Amendments Act). Secondly - coincidentally - we’ve just hit the $500,000,000 mark in unclaimed fines for the FDA.

In the 6 months since launch, the FDAAA TrialsTracker has been visited over 50,000 times (with over 44% originating from organic searches such as people googling clinical trial IDs!). Along the way we’ve assessed the results status of over 1,200 trials on a daily basis. As of today just 60.2% of these trials have reported results within 1 year + 30 days of their primary completion date. Full details of how the tracker works can be found here. Our data makes it clear that many trials are in clear violation of the FDA Amendments Act 2007 (FDAAA 2007) and its recent Final Rule. This is disturbing, to say the least.

Equally disturbing is that no one seems to be doing much about it. The FDAAA 2007 Final Rule gives the FDA the power to fine non-compliant sponsors $11,569 for each day a trial remains unreported following a 30-day notification period. We have been tracking the maximum amount of fines that the FDA could have collected if sponsors were notified of overdue trials immediately and, as we said: today that amount surpassed a half-billion dollars. Despite this impressive sum, we have seen no evidence that the FDA has issued a single dollar in fines for non-reporting to date; nor, indeed, a single formal warning.

It will be difficult to improve compliance with the FDAAA 2007 in the absence of serious enforcement action by the FDA. However we have a number of efforts underway to keep pressure on the FDA and trial sponsors, and help ensure results are reported in accordance with the law:

1. We will continue with regular updates to the FDAAA TrialsTracker.
2. Our Unreported Trial of the Week series at The BMJ spotlights individual unreported trials and focuses on their very real impact for patients, practitioners, and policymakers. Our 19th installment covering a trial of nicotine replacement for smoking cessation during pregnancy was published yesterday.
3. Along with our colleagues at the AllTrials Campaign, we will continue to send weekly letters to the FDA informing them of the extent of non-compliance with the FDAAA 2007 as well as requesting updates related to enforcement of the law.
4. We are working on a number of papers analysing the data we have collected through our FDAAA TrialsTracker related to compliance with the law, and other issues around trial registration and reporting on ClinicalTrials.gov.

We are very concerned by slow progress: the medical community waited many years for the FDAAA to be created, and it is very unhelpful to see it so widely ignored. We hope at the very least that nobody will use the existence of this law to give false reassurance on the realities of non-reporting.

However, we are always optimistic, and look forward to more forward movement. If you have any suggestions of more things we could do to push things forward, please do, as ever, let us know! You can always contact us, directly, at bennett@phc.ox.ac.uk.