New study shows that 89% of clinical trials run by European universities violate EU regulations

13 Sep 2018

Data released today show that thousands of clinical trials conducted in Europe violate EU rules that require results to be published within 12 months. Failure to publish trial results endangers patients, contributes to exploding drug costs, and slows down the discovery of new treatments and cures.

 

KEY TAKEAWAYS

 

  • Half of assessed clinical trials, 3,673 in total, are demonstrably in violation of EU rules

  • The true number of violations is likely to be far higher, as the researchers excluded 3,392 trials with incomplete registry entries

  • 89% of trials sponsored by universities across Europe are missing results

  • Around a quarter of all trials have never published results anywhere, meaning that many potentially life-saving medical discoveries are in danger of being lost forever

  • National governments across Europe are failing to enforce compliance with regulations designed to strengthen public health and protect patients

 

MOST UNIVERSITIES HAVE A TERRIBLE TRACK RECORD

 

Universities perform far worse than drug companies.

Only 11% of university-sponsored trials have posted results.

 

Against this low baseline, the universities of Dundee and Oxford stand out as the best academic performers by far, with results posted for over three quarters of their trials. Over twenty major European medical research universities have not posted any results at all. The worst performer is the Charite in Berlin, which has posted not a single result for at least 63 completed trials.

 

The table below shows the best and worst performers among universities with fifty trials or more.

In contrast, several large pharmaceutical companies have posted results for all of their due trials, illustrating that full compliance is feasible. Most major commercial players have compliance rates of over 85%. 

 

Non-profit research institutes and hospitals also performed far worse than ‘Big Pharma’. 

 

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

 

- Síle Lane, head of campaigns, Sense about Science

 

Visit this fantastic interactive website created by EBM Data Lab to discover which companies and universities in your country are acting in patients’ best interests - and which are not.

See also this accompanying study published today in the BMJ.

 

 

DOES THIS REALLY AFFECT PEOPLE IN THE REAL WORLD?

 

Yes. It directly harms patients.

 

See this powerful human interest story by a patient and this doctor's personal account

 

 

"As a breast cancer patient who is alive today thanks to being able to participate in a clinical trial, I know exactly how important transparency is. We need to know that the results of those trials are being fully reported to learn honest lessons about what works and what doesn't. We need to have all the evidence at our disposal when we put a new pill into our bodies. Governments across Europe must take urgent action to deliver the transparency our health relies upon."

 

- Lesley Stephen, Edinburgh

cancer patient and JustTreatment patient leader

 

This slideshow provides a brief introduction to the key issues, and these six case studies and this in-depth report document the full scale of the damage caused by unreported and misreported trials.

 

And it contributes to exploding health care costs.

 

Failure to report trial results also contributes to the exploding costs of health care. Numerous studies have consistently shown that clinical trials with positive outcomes are far more likely to report their results. This means that new, expensive drugs appear to be far more effective and safe than they really are. As a result, public health systems, private insurers and individual patients are often paying for expensive drugs when cheaper, generic alternatives would be the better treatment option.

 

“We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported. All trial sponsors - especially universities - must get their house in order now.”

 

- Dr Ben Goldacre, lead author of today's study and co-founder of the AllTrials campaign

 

Finally, medical research funding worth $85 billion is needlessly wasted worldwide every year because research results are not reported. Most research done by universities is publicly funded. 

 

HOW CAN THE PROBLEM BE FIXED?

 

In 2017, Transparency International, Cochrane, CRIT and TranspariMED called on governments to enforce existing rules for clinical trials reporting, and strengthen their legal and regulatory frameworks.

 

“National governments across Europe have a duty to protect the health of their citizens, and to ensure that publicly funded research actually benefits the public. Institutions conducting research in human volunteers should not be allowed to violate the rules with impunity. Governments must take action immediately to ensure that companies and universities share the results of potentially life-saving medical research, past, present and future.”

 

- Dr Till Bruckner, founder of TranspariMED

 

“Transparency over clinical trials is important to ensure public health agencies are making informed decisions and spending public money in the best possible way. These new figures underline the extent to which there is still a serious lack of transparency over the results of clinical trials in the EU. This is despite EU guidelines that require the publication of summary results for clinical trials on the EU trials registry.

If these guidelines are to be effective, the European Medicines Agency, as well as national regulators, must put into place monitoring and enforcement mechanisms that sanction trial sponsors that fail to comply.”

 

- Rachel Cooper, Director of Transparency International Pharmaceuticals & Health

(see also TI's press release)

 

“Regulators must enforce monitoring mechanisms and apply sanctions in case of non-compliance.”

- Yannis Natsis, policy manager, European Public Health Alliance

 

WHAT IS THE LEGAL AND REGULATORY FRAMEWORK?

 

In sum, the EU rules already on the books are not being enforced, the European Medicines Agency is not doing its job, and national governments across Europe have failed to act to protect patients and prevent public research funding from going to waste.

 

The European Union set December 2016 as the final date for compliance with its results posting rule. Under EU rules, the European Medicines Agency is required to publicly flag any trial that is overdue and contact the sponsor, but it has done neither of those things.

 

The EU Clinical Trials Regulation, which will come into force in late 2019, states that “Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.”

 

TranspariMED is not aware of any of the 28 EU member states preparing to adopt such rules or laws. Unless they do so, the transparency provisions of the EU Clinical Trials Regulation will have little effect. Note that member states are free to pass such rules today – they do not have to wait for the EU to make the first move.

 

WHAT ARE THE COUNTER-ARGUMENTS?

 

Some universities might argue that they have already published some of the missing trial results in academic journals. That argument is void.

 

The EU rules are crystal clear: all trials registered on the European registry must post results there within 12 months of trial completion. The WHO also recommends that all trials post their results on registries within 12 months. There are good reasons for this.

 

Multiple studies show that summary results posted onto registries are more complete and accurate than journal publications. In addition, getting results published in journals typically takes two or three years, so sharing results on registries after just 12 months significantly speeds up the discovery of new treatments, vaccines, and cures.

 

In addition, a review of a random sample of trials missing results on the EU registry found that less than half of them had published results in an academic journal. This suggests that the medical insights generated by over 1,400 European trials are in acute danger of being lost forever.

 

“Non-publication of results means that time and public money invested in the research is wasted, and risks crucial health-related decisions being made without access to all the facts. Some universities are taking this seriously, but far too many have a poor record. Universities need to get their house in order.”

 

- Norman Lamb MP

Chair of the UK House of Commons

Science and Technology Committee

 

 

WHAT CAN I DO TO HELP SOLVE THIS PROBLEM?

 

If you want to get actively involved or support our work, please contact TranspariMED. We’re volunteers operating on a shoestring and can use all the help we can get.

 

If you work at a university in Europe, or work for a research funding agency:

 

Encourage your institution to sign up to the WHO Joint Statement and put into place policies and processes that are in line with WHO best practices. Share this article discussing how the University of Dundee became Europe's front-runner in clinical trial transparency, and point out that some top US universities have already achieved full compliance with US laws by systematically tackling the problem. TranspariMED will soon publish a case study detailing how a leading UK university is rapidly moving towards full compliance - keep an eye on this blog.

 

If you are a medical student:

 

Join Universities Allied for Essential Medicines (UAEM) today to make a real difference. TranspariMED is already working with several UAEM student groups to put pressure on their universities to get their acts together and post missing clinical trial results.

 

If you work for a patient group, advocacy group or think tank:

 

In the near future, TranspariMED will partner with other organizations to directly advocate with the European Medicines Agency and national governments in Europe to adopt and enforce effective rules. Please get in touch if you want to add your voice to the growing chorus demanding an end to impunity.

 

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