ABERDEEN University has launched a probe following claims it failed to follow international ethical guidelines in its clinical trials.

External researchers found failures in the registration of medical trials and shortcomings in the way the results are published.

A University spokesperson said the report, written by campaigners TranspariMED, highlighted “areas where improvements can be made” and promised to carry out an audit.

Higher education bodies have a key role in undertaking clinical research, which can ultimately lead to new medicines coming on to the market. However, in recent years various exposés have revealed how research can be skewed in favour of commercial interests.

Bad practices have included failing to register trials, withholding the results and abandoning tests without revealing the reasons.

However, the World Medical Association, which represents doctors across the world, produced the Declaration of Helsinki that laid down an ethical framework for clinical research.

According to the document all research involving humans must be registered in a publicly-accessible database before “recruitment of the first subject”.

It adds: “Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.”

The Declaration, which aims to benefit doctors and patients, also insists that “negative and inconclusive” results must be published, rather than just the positive data.

In its “rapid external audit” of Aberdeen University’s clinical trials TranspariMED, which campaigns for evidence-based medicine, focused on registration, results posting and whether data posted in online registries was accurate.

The researchers found the University had failed to ensure staff had consistently registered trials before the recruitment of the first participant.

There were also cases where results were not posted within one year of completion and examples in which registries did not contain complete information.

Of 151 Aberdeen University trial register entries, the report concluded that more than 20 were shown to "fall short of best practices”.

The report stated: “The whole point of trial registries is to make comprehensive and accurate information easily accessible. Doctors and patients cannot be expected to conduct elaborate and time-intensive searches every time they want to discover, for example, whether a certain trial is still ongoing or results have been published."

Meanwhile, some of the world’s largest research funders and non-governmental organisations last week agreed to adopt tough new standards on clinical trial transparency.

In a joint statement nine funders, including Médecins Sans Frontières and the UK Medical Research Council, agreed to develop policies that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available register.

TranspariMED said of the Aberdeen audit: “There is a clear ethical imperative to post the results of all clinical trials, regardless of the registry used or the intricacies of national legislation. We encourage the University of Aberdeen to use its forthcoming review and audit to ensure that results are posted for all trials, across all registries.”

A spokesperson for the University said: “The University of Aberdeen is committed to ensuring transparency in research, avoiding selective publication, and making results readily available to the public.

“We already ensure that publication and dissemination of results is brought up in our GCP training so that researchers are made aware of their responsibilities as early as possible, and weekly checks are made on Clinicaltrials.Gov to review any problem records and act upon them. There is no requirement to post results onto this register as none of our trials have as yet fallen under the FDA regulation. This audit report has helped highlight areas where improvements can be made. We plan to carry out an audit of the (known) registry entries and to review our oversight processes.”

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