We are grateful to the BMJ who published the article below on a campaign calling for all clinical trial results to be published. Whether trial results are good or bad – or even if the trial is stopped – it’s important the public knows all outcomes, in the name of patient safety.

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The BMJ article by journalist Elisabeth Mahase.

The UK government must deliver on clinical trial transparency promises and align medical device requirements with those in place for medicinal products, research and patient groups have told health secretary Steve Barclay.

In a letter sent to Barclay on 15 June 2023 and seen by The BMJ, seven campaigning groups—including Sling The Mesh, Cochrane Collaboration and Action against Medical Accidents—urged the government to provide the Health Research Authority (HRA) with the resources needed to ensure that all UK clinical trials are registered and results are publicly reported.

“There is unanimous consensus among experts that failures to register and report the outcomes of clinical trials distort the medical evidence base, impede scientific progress, harm patients, and undermine public health,” the letter said.

HRA launched the Make it Public campaign in July 2020 in response to a Commons science, innovation, and technology committee report two years earlier which found that one in five UK clinical trials do not appear on a public registry and one in four clinical trials of drugs don’t publish results on time.1 The campaign’s aim is to ensure all clinical trials in the UK are registered and all results are made public.

While HRA requires sponsors seeking research approval to explain how they will share the results, it does not have the resources to chase overdue results.

Additionally, although clinical trials of drugs are automatically registered, this does not happen for trials of medical devices, surgery, public health, and behavioural interventions. Instead, trial sponsors are expected to register these themselves—something that does not always happen.

HRA’s latest report (2022 – 2023) found that 8% of UK clinical trials are still not being adequately registered and there is no monitoring in place to see whether results are being made public.

Speaking to The BMJ, letter signatory Kath Sansom, founder of patients’ campaigning group Sling The Mesh, said, “It’s crucial for patient safety that we can see all the trials data, so that clinicians and patients can make fully informed decisions on the risk v benefits of treatments. If data is missing, it means we don’t have the full picture of potential harms.”

Medical device trials

As well as providing HRA with the investment it needs, the letter called on the government to align transparency requirements for medicinal product and medical device trials – something they argue could be done at “no cost and would not require parliament to pass new legislation.”

Earlier this year, the government said it intended to make it a legal requirement to register and make public the results of clinical trials involving medicinal products.

“Identical requirements should also be adopted for clinical trials of medical devices,” the letter said. “There is no sound regulatory, scientific, clinical, or ethical reason for applying different transparency standards to clinical trials of medicinal products and clinical trials of medical devices. There is no reason why a clinical trial of a pacemaker should be subject to lower transparency standards than a clinical trial of aspirin.”

Cochrane advocacy and partnerships lead Emma Thompson, a signatory of the letter, told The BMJ: “The improvements we have seen in terms of registering and reporting drug trials in recent years are welcome. It is time, however, to replicate some of these efforts for other types of trial which also have major implications for people’s health —such as for medical devices.”

In a separate letter seen by The BMJ, the groups called on MP Greg Clark, who chairs the science, innovation and technology committee, to convene a follow-up session on its 2018 report to assess whether HRA has received the resources it needs to “fully implement” the Make It Public strategy, and to clarify   the timeline for the strategy’s full implementation.

Other signatories on the two letters included Consilium Scientific, HealthSense UK, Sense about Science, Transparency International Global Health, and researchers at the University of Oxford’s Bennett Institute for Applied Data Science. The letter was coordinated by TranspariMED — a UK based initiative working to promote clinical trial transparency.

Government action

Responding to the letter sent to Barclay, a Department of Health and Social Care spokesperson said, “We’re investing £81m over three years to improve the transparency and ease of access to data on trialsand the National Institute for Health and Care Research has rigorous processes in place to monitor this.

“The government welcomed all recommendations from the O’Shaughnessy review and will provide an implementation update in the autumn, outlining progress against these commitments.”

The O’Shaughnessy review, published in March 2023, looked at commercial clinical trials and recommended the government aim to double the number of people taking part in commercial clinical trials in the next two years and double it again by 2027.

Following this, the government made five headline commitments backed by £121m—a mix of new and existing funding—to speed up trials and improve access to real time data.

Health Research Authority. Make it public New strategy marks step change in making health research findings available to the public. 30 Jul 2020.

Health Research transparency annual report 2022 March 2023

Wise J. Clinical trials: Streamlined framework aims to boost UK research. BMJ 2023;380:. doi: 10.1136/bmj.p696 pmid: 36958751

Wise J. Give doctors financial incentives to take part in clinical trials, review recommends. BMJ 2023;381:. doi: 10.1136/bmj.p1226 pmid: 37253476