The FDA Amendment Act 2007 says that lots of clinical trials in the US should be registered on ClinicalTrials.gov and report results information there within 12 months of the end of the trial. AllTrials’s FDAAA TrialsTracker shows that 628 clinical trials have broken this law since the first trials became due in January this year. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.

The US’s Food and Drug Administration has at last published its plan to identify and punish the organisations and people who have broken the law by not reporting clinical trial results. The FDA now wants to hear what we think about the plan. The draft guidance is open to public comment, and you don’t need to be a US citizen to get involved.

If you would like the FDA to start fining the people and organisation who break the law on reporting results please tell them here that you welcome the publication of the guidelines and hope they are implemented soon. To submit a more detailed comment, please do it here before November 20 2018.