AllTrials puts FDA under pressure with Trials Tracker
pharmafile | February 22, 2018 | News story | Medical Communications | alltrials, biotech, drugs, pharma, pharmaceutical
A year to the day that the FDA unveiled its Final Rule, which sees organisation given 13 months from clinical trial completion to publish summary results and adverse events, AllTrials announced a website that would track compliance.
AllTrials revealed a website that automatically pulls data from clinicaltrials.gov and effectively names-and-shames those companies or organisations that have not posted results for their trials.
Alongside this, AllTrials submitted an open letter to Scott Gottlieb, Commissioner of the FDA, calling on the agency to uphold its threat of fining those non-compliant with the requirement $10,000 per day.
Explaining the decision, the letter, written by Ben Goldacre and Siles Lane, reads: “Using ClinicalTrials.gov’s data, it identifies trials that are subject to FDAAA 2007 as they reach 13 months from completion date and flags missing results. As the list grows each week, the website will show a ranking of the sponsors with the most trials that appear in the data to be in breach of the law. It will also display an estimate of the total amount in fines that the FDA could levy in response to these breaches.”
It continues, “We know that the FDA takes patient safety seriously and we are sure that you will follow the tracker to act on unreported trials. However, to assist you further we will also write weekly with the list of trials that have breached their reporting requirements and a rolling total of the fines that these should incur.”
AllTrials is a not-for-profit group aimed at ensuring that results from all trials conducted have their outcomes published to ensure that doctors and patients can use the results to form decisions. As well as this, clinical trial results form the bedrock of future investigations and transparency of outcomes allows researchers to more efficiently develop new treatments.
Already some organisations have reacted to the website, with the BBC reporting that Imperial College London had submitted missing results after being contacted.
The main hope for the website will be that it puts pressure on the FDA to be more ruthless when it comes to chasing the publishing of data.
The read out from the website, currently looks like this:
Ben Hargreaves
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