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MPs demand doctors get full access to clinical trials data

Only half of completed trials are published, says report

Adrian O'Dowd

Friday, 03 January 2014

Doctors and researchers should be able to see all results from clinical trials of all treatments currently used in the UK, according to MPs.

The MPs on the parliamentary public accounts committee have today published a highly critical report on access to clinical trial information and the stockpiling of Tamiflu.

They raise many concerns about the current system of clinical trials in the UK, saying that the probability of all completed trials being published is roughly 50% and trials that give a favourable verdict are about twice as likely to be published as trials giving unfavourable results.

Information is routinely withheld from doctors and researchers about the methods and results of clinical trials on treatments that are currently prescribed in the UK, says the report, and despite awareness of this problem for many years, the government, industry and professional bodies have not taken sufficient steps to address it.

The committee’s MPs called on the government to ensure that full methods and results from clinical trials of all treatments currently used in the UK are made available to doctors and researchers.

They also recommended the Department of Health and the MHRA ensured that clinical trials, past and future, were registered on an appropriate register and that the full methods and results were available for independent scrutiny.

Ensuring information from past trials was available to researchers was important they said, because, most of the medicines used today were tested in clinical trials over the last few decades but around half of these trials had not reported results information on what was found about medicines.

Concerns were also raised about the fact that the Department of Health did not have all the information about Tamiflu – Roche’s branded form of oseltamivir, which was used to treat pandemic flu in 2009-10– before it made the decision to stockpile it at a cost of £424m between 2006-07 and 2012-13 for almost 40 million units.

Richard Bacon, committee member and Conservative MP for South Norfolk, said: “The full results of clinical trials are being routinely and legally withheld from doctors and researchers by the manufacturers of medicines.

“This has ramifications for the whole of medicine. The ability of doctors, researchers and patients to make informed decisions about treatments is being undermined.”

Tracey Brown, director of campaigning group Sense About Science, which co-founded AllTrials – the campaign for all clinical trials to be registered and results reported – said: “Today’s report adds to the clamour of voices calling for more information from clinical trials to be available.

“Now is the time for all companies and academic trialists to commit to registering and reporting results from trials. There is no excuse for not publishing results but a huge public benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients.”

A Department of Health spokesperson said: “We agree that clinical trials need to be more open and transparent and we're working with health organisations in the UK and EU to make this happen. All clinical trials conducted in the UK must now be registered on a public database.

“Patients have rightly been concerned about confidentiality in trials so we need to balance the need to make trials more open with making sure patient data is kept safely and confidentially.”

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