Online tool reveals up to 100% of research trials are never disclosed

20161108140000, Brenda Lau
Up to 100% of trials were found to be left undisclosed by research institutions and drug makers
Up to 100% of trials were found to be left undisclosed by research institutions and drug makers
A consortium of researchers and medical journals, AllTrials, has launched a tool in a movement to push for more transparency from the pharmaceutical industry, healthcare organisations and research institutions.

The new online tool has uncovered that the results for almost half of all clinical trials conducted by drug makers in the past decade have not been published. Drug makers are not the only ones, as an investigation by STAT News found that many universities, medical centres and prestigious research institutions in the US have violated the federal law as they never reported their study results to the ClinicalTrials.gov - the federal database that the tool also sifts through for information.

Four of the top 10 recipients of federal medical research funding from the National Institutes of Health were Stanford University, the University of Pennsylvania, the University of Pittsburgh and the University of California, San Diego. All either disclosed their results much later or not at all about 95% of the time since 2008 when reporting was compulsory.

The US government can impose fined on these institutions or suspend their funding and would have collected at least USD25 billion from drug companies alone in the past seven years, but not a single fine has been given out.

“Everyone has been talking about this problem for far too long,” said Dr. Ben Goldacre, who is a founder of the AllTrials campaign, in a statement. “If any institution is concerned that it is doing badly in our tables, then there is one simple thing they can do: publish their trial results, using their trial registry number, so that this information can be accessed and read by doctors, researchers and patients.”

The transparency issue was deemed important and contentious as without access to such data, doctors and independent researchers are unable to verify results that can further improve treatments, better health care and lower costs. Patients are also unable to verify if a certain drug is 100% safe for them.

Up to 100% of trials were undisclosed by research institutions and drug makers

The tool found that topping the list, Ranbaxy Laboratories have never disclosed results of nearly three dozen trials in the past decade, Sanofi did not report 65% (285 of 435 eligible trials) of their findings, Novartis hid 38% of their trials (201 of 534 trials) and GSK did not release 23% (183 of 809 trials) of their findings. These included trials completed between January 2006 to 2014 and includes sponsors with more than 30 trials, excluding Phase 1 trials.

“In line with regulatory requirements and industry recommendations on voluntary disclosure, Sanofi systematically registers studies and discloses results on public registries, such as ClinicalTrials.gov and the EU-Clinical Trial Register. We also disclose certain results on our corporate website, in peer-reviewed medical/scientific journals and/or at medical congresses," a Sanofi spokesman said.

But research institutions around the world are also guilty of this.

The National Cancer Institute failed to report 35% (194 of 558 studies) of eligible trials. Yonsei University in South Korea never reported 71.6% (139 of 194 studies) of eligible trials. The City of Hope National Medical Center in California was also found to be among the top 5 sponsors of clinical trials with the largest proportion of missing results - 88% (39 of 44 trials).

Top 20 trial sponsors that disclose results are all drug makers

On the positive side, the tool found some companies which were transparent. AllTrials found that the top 20 trial sponsors with the lowest proportion of unreported findings, were all drug makers - with Shire taking the lead, publishing all 96 trial results over the past decade.

Many drug safety scandals have erupted in recent years, forcing legal action to be taken, resulting in the discovery of undisclosed trial results for some drugs. Therefore, many including AllTrials have pushed companies and research institutions to make more detailed trial data available.

The movement has initiated action from some drug makers and research institutions to comply, but a uniform approach to disclosure remains to be set in stone. MIMS

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Sources:
https://www.statnews.com/2015/12/13/clinical-trials-investigation/
https://trialstracker.ebmdatalab.net/#/
https://www.statnews.com/pharmalot/2016/08/04/pediatrics-clinical-trials-data/
https://www.statnews.com/pharmalot/2016/11/03/clinical-trials-sanofi-shire-glaxo/