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Audit exposes gaps in pharma's promises on trial transparency

Study group estimates nearly half of all clinical trials go unpublished

Most pharma companies have said they will register and report the results of clinical trials, but there are huge gaps between them in their interpretation of those pledges, says a new study.

An audit of 42 top manufacturers from the EU, US and Japan by the trial transparency pressure group AllTrials reveals that GlaxoSmithKline sits at the top of the tree for transparency, followed by LEO Pharma, Takeda, Pfizer, Novartis, Novo Nordisk, Boehringer Ingelheim, Amgen, Merck & Co and AbbVie.

At the other end of the scale lie Valeant, Sigma-Tau, Gilead, Esteve, Dainippon Sunitomo, Alkermes and Abbott - all of which scored zero on the policy transparency index.

"In medicine we use the results of clinical trials to make informed treatments about which treatments work best; but the results of clinical trials are being routinely and legally withheld from doctors, researchers, and patients," said Ben Goldacre, lead author of the paper, and a key figure in the AllTrials campaign to improve transparency. The group estimates that nearly half of all clinical trials go unpublished.

The audit looks at the public commitments made by the world's largest drug companies on transparency - focusing on registering trials, revealing methods and summary results and publishing clinical study reports (CSRs) and individual patient data (IPD) - and gauges how well they meet a reference standard. The standard holds that all trials should be registered, with methods and summary results reported within 12 months of completion, and CSRs made available if created, with IPD available on request.

The audit - which is published in the British Medical Journal - reveals that the commitments made by pharma companies were ‘highly variable’. It also found that most of the elements in the reference standard were met by at least one company, showing that the targets are realistic and achievable.

Most of the largest companies, though not all, have a publicly-stated policy about registering and reporting results from current trials, but only around half refer to trials carried out in the past, and policies often fail to mention unlicensed treatments, off-label uses or phase IV (post-marketing) trials.

The researchers also found that company policies are ‘often vague, ambiguously worded, internally contradictory or difficult to interpret’, according to AllTrials.

Just over half of the companies included in the audit responded to the researchers, according to the paper, and 10 of these said they were changing their public policies, with four indicating this was a direct result of the research.

"To make this easier, our paper includes a simple boiler-plate transparency policy that any company can modify and use," said Goldacre.

AllTrials says it is now able to identify unreported trials and ‘over the next two years we will be pursuing them. We would advise anyone who is sitting on an unpublished trial to move quickly to get the results reported, before we get to it’.

Meanwhile, transparency "is a problem for industry sponsored trials, and for trials funded by governments and charities", according to Goldacre. The latter will be the subject of an audit due for publication soon.

Article by
Phil Taylor

28th July 2017

From: Research



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