Patients at risk as UK universities fail to disclose results of clinical trials

Patients at risk as UK universities fail to disclose results of clinical trials

The report looked at trials registered on the European Union clinical trial registry and the United States registry, – these are the main registries used by UK researchers.

Of the 254 UK university trials listed on the EU registry whose results are now due, 96 are missing results.

The strongest performers on the European registry are Aberdeen University, which reported 100 per cent of trials, and King’s College, London, which reported 96 per cent.

But the record on the US registry is very poor. The 27 universities covered by this report have sponsored 1624 clinical trials listed on the US registry but 97 per cent of the results are not yet been shared.

Imperial College, London has reported just 10 of the 239 trials due and the University of Oxford has reported the results of just seven trials, with 227 now overdue. 

While Nottingham University’s record looks poor, reporting less than 10 per cent of trials, the report highlights that it has recently made progress, uploading data on seven trials in recent months. 

Examples of where missing data has had an impact on public health include Tamiflu: a flu drug recommended by the WHO and stockpiled by many governments around the world, including the UK which spent £500m on it, to use during the 2009 swine flu epidemic.

However, it soon became clear that the drug’s side effects outweighed its benefits but WHO had already made its recommendations on the basis of incomplete evidence.

One of the Transparimed report’s authors, Till Bruckner, said that reasons for not reporting results were complex – the registries were unwieldy to use and academics may not have the time and resources to report the results. 

He said that the government had failed to ensure that researchers comply with their “legal, scientific and ethical obligations”.

A report by the UK Parliament science and technology committee last year found that 50 per cent of clinical trials go unreported.

Dr Bruckner added: “We need sanctions in place for universities, NHS trusts and pharmaceutical companies that fail to follow the rules. The Science and Technology Committee was very clear that the government should not only monitor compliance but also impose sanctions. It would be reasonable to give institutions a year to clean up their act.

“Our aim is not to punish people but to develop positive compliance and get institutions to do the right thing.”

A spokesman for Imperial College said: “Imperial College London advises its researchers that, in addition to registering trials before patients are enrolled, they should publish results in the registry once the trial has concluded. We are taking steps to make sure all co-ordinating investigators are reminded of the importance of doing this so that the results of research are freely available.”

The Science and Technology Committee has said it will demand that universities explain themselves before MPs if they do not clean up their act.

Norman Lamb MP, chair of the committee, said universities and others conducting trials needed to publish their results as a matter of urgency. 

He added: “Our committee will be returning to this issue in the summer with a follow-up evidence session, so I’m putting all universities and NHS trusts on notice that they will be asked to come before us to explain themselves if they haven’t got their house in order by then.”

Dr Ben Goldacre, a researcher at the University of Oxford and co-founder of the All Trials campaign, said: “We will closely monitor clinical trial reporting across all UK universities over the next six months. We are delighted that MPs are paying close attention to this data. Our sole objective is to help universities improve their reporting performance. We urge them to get in touch if they have any questions.”

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