Half of medical trial results kept secret

Almost half of all clinical trials worldwide still go unpublished despite repeated warnings that pharmaceutical companies and universities are endangering the public by not revealing the results of their research.

A new tool developed by scientists at the University of Oxford to automatically track the publication of medical research found that the results of more than 11,000 trials involving an estimated 8.7 million people, or 45 per cent of all trials performed in the past decade, remain unknown.

They called it a “completely unethical” situation which meant that doctors were unable to prescribe drugs effectively.

“We cannot make informed decisions about which treatments work best with patients unless we have access to all the results of the trials for treatments in use today,” Ben Goldacre, one of the researchers, said.

“We know these are being routinely and legally withheld from doctors and researchers.”

Sanofi, the French pharmaceutical company, was accused of not providing the results in 285 trials — two thirds of all research undertaken by the company since 2006.

Sanofi insisted that it adhered to regulatory requirements and voluntary industry standards.

The most open companies included Johnson & Johnson, which reported 95 per cent of trials, and Pfizer, which reported 87 per cent.

Campaigners have long been concerned that by not publishing trials, researchers are skewing our assessment of whether treatments work.

Previous investigations have suggested that medical researchers have been guilty of systematically withholding trials that fail to show an intervention is successful. This means that treatments can appear to be more effective than they really are.

In the UK there is no law that says trials must be registered or reported. Within the EU a new directive is planned to come into force either next year or in 2018 requiring that any trial must be registered and published.

The new website, called TrialsTracker, automatically scans a US register of trials undertaken and compares it to published results on that register and on PubMed, the standard database used by researchers.

The scientists, whose findings are published in the journal F1000 Research, said that they hoped that having a freely available research tool to rank companies and institutions on transparency would “hold their feet to the fire”. They also hoped it would pressure them to release previous results.

Jacintha Sivarajah, head of medical affairs at the Association of the British Pharmaceutical Industry, said: “The ABPI has long been an advocate of greater transparency in clinical trial data balanced with the need to protect patients’ personal data, companies’ intellectual property rights and confidential commercial information.”

She added: “Our own research shows that disclosure rates for UK and EU trials has risen year on year for the past decade and now stands at 90 per cent.”

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Meredith Weisser

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