Half of European studies fail to report results: BMJ

New research out by the BMJ shows that half of tracked clinical trials across Europe "have not reported trials," but biopharmas are doing much better than their academic peers when it comes to disclosing data.

These new data are out from the EUTrialsTracker tool, with the accompanying paper led by one of the AllTrials founders, Dr. Ben Goldacre, also director of the DataLab at the University of Oxford and Bad Pharma author.

The tracker was launched today and shows that 48.9% of clinical trials that should have reported results haven’t, with only 51.1% of clinical trials having reported results.

Although the ones often getting the bad press, the majority of major pharma companies "are coming close to complying with reporting rules," the report noted, while the majority of major academic institutes are not.

Breaking this down, the data show that 68% of company-sponsored trials have reported results against just 11% of academic trials.

Current EU clinical trial rules say results must be reported onto the EU clinical trial register for every trial on the register within a year of the end of a test, but the paper pointed out that "no one has ever been sanctioned for breaking the European rules." Tougher rules are set to come into force next year.

It also noted that: "The data on the EU register is so riddled with mistakes and inconsistencies that it will be impossible for the European regulator to fully assess compliance for every clinical trial."

The AllTrials campaign group, which for around five years has been pushing for greater trial transparency, said that "there are no excuses for academics' poor reporting rates."

In a further bright spot for the industry, some pharma companies are reporting all of their trials, with the EUTrialsTracker currently shows that 11 major commercial sponsors are achieving 100% reporting.

These include: Boehringer Ingelheim, Almirall, Gilead, Otsuka, Vertex, Genentech and LEO Pharma. Others still managed more than 90%, including big players Novartis, Sanofi, Pfizer, AstraZeneca and GSK.

Most of the pharma companies were reporting above 80%, with Pierre Fabre at 55%, Baxter at 60.7%, Celgene at 72.7% and Teva at 76.9%, among the lowest.

On the flipside, the 32 major academic sponsors with 0% compliance include the Karolinska Institute, University of Copenhagen, Manchester University NHS Foundation Trust, University of Amsterdam, Hospitals of Paris, Erasamus University and the European Institute of Oncology and the National Cancer Institute Italy.

Meanwhile, the top-performing major academic sponsor, the University of Dundee in the U.K., is reporting 82% of its trials, but most academic sponsors are reporting less than 50% of due trials.

But the report noted that larger sponsors, those with most trials on the register, are "significantly more likely" to have reported results than smaller sponsors.

It’s a mixed picture, and one better for biopharma than universities, but clearly, more needs to be done if companies and academic centers in particular are to reach a 100% hit rate on reporting. There are also thousands of trials that were killed off or completed, but still not taken into account by the tracker because of issues of dating, making the picture ever murkier.

Goldacre said, "This problem strikes to the heart of evidence-based medicine. We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported.

"We would hope that public pressure and the ethical need for trial reporting should be enough. But the EU Clinical Trials Regulation is coming into force next year. It will bring substantial financial penalties for sponsors in breach of reporting requirements. All trial sponsors, especially universities, must get their house in order now."

Síle Lane, head of international campaigns and policy, Sense about Science, added, "The new tracker shows us that some companies and universities are taking this issue seriously. But there’s a vast difference between the best and the worst. There’s no excuse for failing to report results.

"So, why should Helsinki University be allowed to run one more trial, while they have not posted results for any of their 12 currently overdue trials? Or the University of Nottingham, which has reported results for just 1 out of their 17 overdue trials on the register?

"Why should these institutions be allowed to run any more drug trials on patients? Why are ethics committees giving them permission to run more trials? Why are funders paying for them?"

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