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German agency calls for sanctions on universities that fail to share clinical trial data

The German agency responsible for assessing the efficacy of medical treatments has proposed imposing sanctions on universities that fail to share clinical trial data.

Responding to a study showing that 89% of clinical trials sponsored by European universities violate EU transparency rules, IQWIG’s director, Professor Jürgen Windeler, commented that:

“The fact that tax-funded universities are not fulfilling their legal obligations is particularly regrettable. There are substantial deficits in investigator-initiated trials with regard to data transparency – and sanctions are seemingly required to quickly change this. On several previous occasions, the Institute experienced that clinical trial investigators at universities withheld data.”

IQWIG emphasized that the failure to report results is not a victimless crime:

“The Institute could not draw a conclusion on the benefit or harm of stem cell transplantation for multiple myeloma because even more than 10 years after their completion, three large trials had still not been fully published. Two of these trials were under German supervision (universities of Heidelberg and Würzburg).

The fact that clinical trials are not registered and their results are not reported is not a trivial offence. Rather, ethical and scientific standards are being violated, because the benefit and harm of medical interventions can only be correctly assessed on the basis of complete data. Only then can physicians and patients decide on the best-possible alternative.”

Recent data shows that the universities of Heidelberg and Würzburg continue to fall short of basic tranparency requirements.

Between them, the universities have failed to post the results of at least 25 clinical trials involving human volunteers onto the European trials registry. Both are thus in violation of EU transparency regulations.

IQWIG proposed two approaches to monitoring and sanctions:

“One option could be that research funders impose specific requirements. They should check whether an applicant has completely reported its previously funded project in the EU Register and, if applicable, refuse further funding.

As trials are also conducted without public funding, in addition, ethics committees should also monitor whether legal regulations such as inclusion of a trial in the EU Register are being followed, because these committees know all trials conducted in a certain region or university.”

Both approaches proposed by IQWIG have wide support among the global medical research community:

Funder audits

  • The WHO recommends that funder policies should ensure that “the contribution made from reporting previous trials, whatever their results, will be considered in the assessment of a funding proposal”.

  • In May 2018, a senior official at the US National Institutes of Health, announced that researchers who fail to register clinical trials and report their results will no longer receive research grants.

  • In August this year, Transparency International, Cochrane and TranspariMED wrote to the 19 largest medical research funders worldwide to ask to what extent their policies were aligned with WHO recommendations.

  • And earlier this month, TranspariMED urged Britain’s NIHR to stop funding researchers who leave clinical trial results unreported.

Ethics committee audits

  • TranspariMED and several other health groups have proposed setting up a National Clinical Trial Audit System in Britain. Under the proposal, the UK’s Health Research Authority would review research ethics committee records it already holds on file to ensure that every trial conducted in the country is registered and reports its results.

  • That proposal is currently being considered by a parliamentary committee, which is expected to publish its report in autumn 2018.

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