After a long and often controversial battle for transparency, the European Medicines Agency will from today become the first regulator to publish clinical study reports (CSRs) in a step toward opening up clinical trial data.
While not the full data set, CSRs are still fairly extensive documents that set out detailed methodology and results of studies coming from biopharmas and academic centers.
The EMA will be the first global medicines regulator to proactively publish the CSRs it receives from companies applying for marketing authorization, which are designed to allow researchers the ability to scrutinize companies’ claims about the safety and effectiveness of new medicines.
“Transparency on clinical data is a longstanding commitment from EMA and today, we are delivering on our promise to give access to the data on which our recommendations are based,” explained EMA Executive Director Guido Rasi. “Our initiative has shaped the global debate towards more transparency. It will benefit academic research and the practice of medicine as a whole.”
On Jan. 1 last year, the EMA set forth new rules that meant all successful applications to the agency from 2015 will eventually be published for public scrutiny in the form of CSRs.
After allowing the industry--which includes pharma, biotech and academia--time to get its data in order, the EMA said that the first lot of reports from 2015 will be published from today.
The move has been welcomed by AllTrials, the U.K.-headquartered pro-transparency group led by Dr. Ben Goldacre, Sense About Science, the BMJ and others, and backed by GlaxoSmithKline ($GSK), NICE and a host of other orgs.
Dr. Síle Lane, director of campaigns and policy at the charity Sense about Science, said: “It is very welcome news that the European Medicines Agency is starting to publish all Clinical Study Reports it receives. The 700 organizations in the AllTrials campaign, who between them represent hundreds of millions of people worldwide, have been calling for this. We all now hope that other global medicines regulators will follow the European Medicines Agency’s great lead.
“The European Medicines Agency’s new policy means there will be a lot more information about our future medicines available for scrutiny. This is fantastic. However, the majority of medicines we use now, and will continue to use for years to come, were approved in the past. And it’s the information on these medicines that remains hidden. Regulators like the European Medicines Agency need to do everything they can to ensure all information about all our medicines is available to doctors and researchers.”
Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said: "Transparency is an essential component in clinical research. Its outcome--whether positive or negative--should be made publicly available. EMA's transparency initiative will make Europe a true front runner with respect to release of data concerning clinical trials. It will create a bridge from now until the new Clinical Trials Regulation--which foresees additional milestones towards transparency, becomes applicable."
This has been a long time coming: The original start date had in fact been January 2014, with the plans for transparency first published all the way back in 2012.
Unhappy pharma companies, many of which have resisted the calls for transparency, have over the past four years fought back against the EMA, hence the delays and compromises over the release of data.
In fact, both InterMune--now owned by Roche ($RHHBY)--and AbbVie ($ABBV) sued the EMA over the potential release of data for their products in 2014, although both dropped the lawsuits after striking a deal with the regulator to limit what the public could see.
Now, after the legal spats and behind-the-scenes negotiations that saw the industry gain new limits on what they have to show, the EMA and AllTrials are keen to chalk up the plans as a victory for transparency.
But problems still persist, and just last month the EMA had to appeal two interim court orders from the president of the General Court of the European Union that seek to block the release of CSRs for meds from PTC Therapeutics ($PTCT) and Intervet. This came despite its new transparency drive, and with redactions in place for the drugs, meaning future battles still loom.
Back in March, the regulator published new guidelines to help with the practical side of things, which includes how the industry can anonymize data (the methodology of which will largely be down to companies) as well as how it can apply to have some data redacted, should it meet the commercial confidential information (CCI) clause.
The EMA said that its guidance “makes clear that the vast majority of the information contained in clinical reports is not considered CCI.” But where this might be the case, companies will need to submit to EMA for review a table justifying why such data have been redacted.
The new guidance clarifies which type of data EMA would typically refuse as being CCI and how the redaction of such data will be handled. The use of CCI was originally absent in the 2012 plans for transparency but crept into its final policy after voices from pharma swayed the agency.
The drugs regulator will also publish the redacted and/or anonymized clinical reports within 60 days of a final decision by the European Commission on new medicines. Applications that are withdrawn will also have their data published, but after 150 days of withdrawal.
The EMA said earlier in the year that it would be reaching out to companies that were “concerned” by the first wave of publications, as well as hosting a live webinar in the second quarter for companies to ask questions about the new policy.
While some are hailing this as a real step change in trial transparency, others have questioned the delays in getting to this point, and the limited data that are being allowed out in dribs and drabs.
Beyond CSRs (which contain only limited information) is also the separate need for the publication of individual patient data--something promised by the EMA in 2012, but a policy that has not made it into the final scope of its new rules.
There is also concern that almost all of the data for the drugs used by doctors and patients will not be made public under the EMA’s rules, as they are only active back to drug applications from the beginning of last year.
But what has been achieved is nothing short of a major shift, in just a few years, from a paternalistic attitude from both pharma and the EMA that believed the data need only be seen by these two groups, to a proactive stance by the regulator and even by some (though not all) in pharma to share this information more widely.