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 FDA Amendment Act 2007 says that lots of clinical trials in […]
A new interactive website, eu.trialstracker.net, shows that 49% of clinical trials on the EU clinical trials register have not reported results. EU rules say clinical trial results must be reported onto the EU register for every trial there within 12 months of the end of the trial. Only 51% of trials on the register are […]
Last year 21 government and philanthropic groups promised to change the way they work. They committed to writing new policy to ensure that all the clinical trials they pay for report their results. This group of funders joined the World Health Organization’s statement on registering and reporting trials and promised to have their new working policy in place within a year. […]
New research shows that most US academic institutions do not have policies to ensure clinical trials run by their researchers are registered and results reported. A survey of 366 universities in the US uncovered that less than half have a policy on registration of clinical trials (43%) and only around a third (35%) have a […]
Most of the world’s largest charities and government bodies who fund clinical trials don’t ask that the results from these trials are reported.
An audit of the stated transparency polices of the 18 philanthropic and public bodies that spend the most money on clinical research has found that most do not require researchers to report results […]
The AllTrials campaign is shining a spotlight on clinical trials that haven’t published results, one per week from now on in the BMJ. Read more about this new series in the BMJ.
The trials we write about will be one of those flagged by the FDAAA Compliance Tracker and, as of 14 September 2018, the EU TrialsTracker […]
Hello hello,
I hope you’ve seen our new tool, the FDAAA TrialsTracker, which identifies every individual clinical trial that fails to report its results, live online. Now everyone can see the individual institutes, companies and researchers responsible for unreported trials, the very day they go overdue.
Three weeks ago we highlighted just one of these overdue […]
With the launch of the FDAAA Trials Tracker, we wrote an open letter to the FDA asking them to act on the unreported trials being publically flagged. We’re writing to them every week with the list of trials in breach of the FDAAA Final Rule as well as how much the FDA could have levied […]
Dr Scott Gottlieb
Commissioner
Food and Drug Administration
16th February 2018
Dear Dr Gottlieb
As the body responsible for compliance with the FDA Amendments Act 2007, you have the power to sanction those who break this law, including the levy of fines up to $10,000 a day against clinical trial sponsors who fail to publish their trial results on ClinicalTrials.gov. […]
A new publication from the Collaboration for Research Integrity and Transparency (CRIT) at Yale Law School and AllTrials supporters Transparency International, TranspariMED and Cochrane calls on governments to ensure that patients, doctors, and scientists can access the full results of all clinical trials.
The groups warn that the current lack of access to complete, unbiased and […]