'Not a minor misdemeanor': New report finds more than 80% of trials are still unreported

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Sean_Kuma)
(Image: Getty/Sean_Kuma)

Related tags: Clinical trials, Transparency, TranspariMED

An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.

A total of 778 clinical trials – 83% of all due trials – conducted by 30 universities in 10 countries are in violation of EU transparency rules and global best practices outlined by the World Health Organisation (WHO), according to a joint report released today by TranspariMED (UK), BUKO Pharma-Kampagne (Germany), Test Aankoop (Belgium), and Health Action International (Netherlands).

"Neglecting to publish clinical trial results is not a minor misdemeanor,” ​said Jörg Schaaber from the German health integrity group BUKO Pharma-Kampagne. “This has direct consequences for patients, who due to evidence gaps may not receive optimal treatment. Results that remain unpublished are a waste of public health funds and of taxpayers' money."

By the numbers

Of the 778 trials missing results, 246 were run by universities in Denmark, 225 in Austria, and 117 in Germany.

However, fourteen universities failed to post a single clinical trial result, including all assessed universities in France, Italy, Norway, and Sweden.

Some universities in Belgium, Germany and the Netherlands also have not posted results for any trials.

Per the report, only three universities perform well, having already posted more than 80% of their trial results: University of Oxford, University College London, and King’s College London.

The UK’s academic sector has an average reporting rate of 69%, highlighted by a reporting rate of over 90% at the University of Oxford and King’s College London. The weakest of the five schools assessed in the UK reported still reported 25% of trials.

This, compared to the nine other countries examined which on average have posted results for only 7% of trials – a reporting rate down from a September 2018 report which found an 11% reporting rate for European universities.

Outside the UK, 730 out of 785 verifiably due trials (93%) are currently missing results.

No university assessed in mainland Europe has a reporting rate of more than 20%, with one exception, per the report. 

Examining the registry data, Dr. Till Bruckner, founder of TranspariMED, said it is striking how many trials that were completed years ago are falsely listed as ongoing.

“This makes it difficult for patients to locate trials that they can enroll in, and thus undermines recruitment efforts by trialists, including in the commercial sector,” ​he told us.

“National regulators are responsible for making these updates, but apart from the MHRA in the UK, it appears that none of them are taking this responsibility seriously,”​ Bruckner said, noting that the problem could be easily fixed at a minimal cost.

While Rachel Cooper, director of Transparency International Health Initiative, said the recent improvements some British universities have made in publishing results “demonstrate what is possible,”​ they “still have some way to go.”

Cooper added that the figures for European universities “remain shameful.”

“The recent improvements in the UK are no doubt related to renewed pressure from Parliamentarians, as well as civil society – but equally demonstrate that where efforts are made to improve transparency, progress can be quick,”​ she told us.

“Patients must be able to trust the medical products they take reflect the fully disclosed history of all relevant research and development and that public money mitigates research waste and delivers full value for money," Cooper said.

In an effort to improve reporting rates, the Health Research Authority (HRA) last week announced​ the formation of the Research Transparency Strategy Group, which met for the first time earlier this month.

The group was created in response to the House of Commons Science and Technology Committee Report on clinical trials transparency. The report, published in October 2018, called on the UK Government to ensure all trials are reported.

According to the HRA, the group will help draft a strategy to be delivered to the committee by December 2019.

Additionally, the Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing and updating the status of all clinical trials listed on the EU Clinical Trials Register (EUCTR) after TranspariMED reviewed nearly 1,000 trials sponsored by universities and found that less than 3% had been marked as completed.

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