Research into clinical trial transparency shows huge variation in standards
A study published in the BMJ displayed the large degree of variation and lack of industry-standard when it comes to revealing clinical trial data.
The research, headed by Ben Goldacre, revealed that all elements of best practice decided by the study were met by at least one company, barring one journal submission of all trials within 12 months. However, individual companies’ commitments varied and pinning down particular publically-available policies proved difficult for those involved in the AllTrials project.
The campaign was begun to counteract the long-standing practice of leaving certain clinical trial studies unpublished. The projects aims to target the lack of transparency on data that could potentially point towards safety issues of currently used treatments, including in off-label prescriptions, which would be highly instructive to medical professionals.
As part of this process, the AllTrials website revealed a company ranking regarding clinical trial transparency. The rankings revealed GSK to be top of leader board while fellow big pharma company Sanofi languished in position 25 out of the 42 companies studied.
This performance was not quite as bad as Valeant, which propped up the bottom of the table scoring 0 points on the index – though it was separated from Abbott only by virtue of alphabetical order.
The paper summarised the results of its study: “Many companies lacked commitments on basic issues such as trial registration and the sharing of summary results. Transparency commitments generally did not include trials for off-label uses, even though these are common in clinical practice; and commonly failed to include phase IV trials. Twenty three companies replied when given our appraisal of their policy. Feedback was lengthy, but often ambiguous, and only had a minor impact on our coding: 0.4% of score elements were changed. However, 10 of the companies who responded informed us they were changing their public policies, and four explicitly stated that this was as a result of feedback from our research.”
This latter point is the real focus of the study, to shine a spotlight on clinical trial transparency and, through the leader board, encourage companies to compete to be seen as the most successful in the area.
There was also a warning that AllTrials is able to discover which trials have been hidden and will pursue those who are withholding them adding another pressure point to encourage the release of data.
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