Clinical studies still not being published
pharmafile | March 4, 2014 | News story | Research and Development, Sales and Marketing | ABPI, EMA, alltrials, clinical trials, csr
Half of all trials registered on a US clinical study database are not being published in public journals.
This is according to a new report from Thomson Reuters Cortellis Clinical Trials, which found that of 600 studies chosen randomly from Clinicaltrials.gov – only 50% had their results published in a journal.
ClinicalTrials.gov is the main registry and results database of publicly and privately supported clinical studies of human drug trials conducted around the world.
The report called ‘Developments in Clinical Trials’, notes that lack or ambiguity in reporting clinical outcome achievement “could potentially be detrimental to clinical healthcare improvements”.
It also found that some of the trials taking place today not only go unpublished, but also unregistered. “This might reduce a patient’s potential to find a suitable treatment, as well as lower the capability of the trial to include an appropriate and representative patient cohort,” the authors say.
This comes at a difficult time for the industry as in Europe new rules by both the European Medicines Agency and the European Parliament are set to be debated over the coming weeks.
In fact on 3 April the Parliament is set to approve a new directive that will require anyone running a clinical trial to register it and publish a summary of results in a publicly accessible EU database.
Currently these types of data are stored on a database that can only be accessed by the EMA. On top of this, full clinical study reports (CSRs) are also expected to be published following marketing authorisation of the product, or if the marketing authorisation is withdrawn.
This will be enforced by fines for any company or group that doesn’t adhere to the new transparency rules. But the industry has been fighting hard against this, arguing that it can self-regulate when it comes to releasing data.
The UK pharma lobby group the ABPI said recently that new analysis – which it commissioned – found that more than three-quarters (76%) of all industry-sponsored clinical trials for new medicines recently approved by the Agency EMA had ‘some results disclosed’ within a year of completion or of regulatory approval.
It also found that rates of disclosure have ‘continued to rise’ and almost nine out of 10 (89%) of these trials had disclosed results by 31 January 2013.
But these data have been criticised by the UK transparency campaign group AllTrials, which says that independent analysis shows the rates of disclosure remain low.
The AllTrials initiative has also maintains that only half of all research studies are published, with those that have positive results appearing twice as frequently as those with negative results.
These latest data from Thomson Reuters Cortellis will only serve to corroborate the stance taken by AllTrials, and fuel greater discussion over this divisive issue ahead of the European debate on the topic next month.
Ben Adams
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