Primary care a weak link in trials, says O’Shaughnessy

Primary care doctors in the UK are a “negligible” provider of commercial clinical trial activity and should be incentivised to give experimental therapies to patients.

That’s just one of a long list of recommendations from a much-anticipated report by former Health Minister Lord James O’Shaughnessy, who was commissioned by the government in February to examine why the UK is falling behind in clinical research – and to suggest ways to reverse the trend.

According to figures from the Association of the British Pharmaceutical Industry (ABPI), there was a 41% decline in new trial initiations between 2017 and 2021.

At the moment, there is too much reliance on hospitals to carry out clinical trials, and general practitioners should be offered financial incentives to help run studies in primary care and ‘at home’ settings, says the report.

To help them, regulators should produce guidance on the use of decentralised clinical trials and other innovative formats, backed by digital health technologies, and work with government on a strategy for the use of artificial intelligence in clinical trial design and regulation.

Another problem highlighted in the report is the lengthy and bureaucratic process for set-up and approval of trials compared to other countries, often taking upwards of six months to complete.

While there have been signs of improvement in this area from the National Contract Value Review – recent data suggest times have reduced from an average of 213 to 118 days – the Medicines and Healthcare products Regulatory Agency (MHRA) should work to drive that down to a 60-day limit, and receive extra funding to achieve that goal.

A standard framework for contacting patients who may be eligible to participate in trials should be set up, and everyone who gets any form of genomic sequencing in the UK should be offered a standard consent for engaging in research.

Systemic issues to be tackled

Overall, there is a lack of transparency and data about commercial clinical trial activity, as well as a lack of accountability for underperformance “at every level”, according to the report, which also notes that research is not prioritised within the NHS.

One solution to that could be to increase the incentives for participation, for example by funnelling income generated by commercial trial sponsors directly back to the units and departments in the NHS that are leading the studies.

The report also recommends setting up clinical trial acceleration networks (CTANs) that are funded and equipped to deliver “genuinely best-in-world clinical trials services,” according to O’Shaughnessy, who said the government should now develop an action plan to revitalise the sector by autumn 2023.

At the heart of the problem is research is simply not being considered enough in UK society as a whole, he said.

“There are many proposals outlined in the review, but perhaps one thing more than any other needs to change: the attitude of everyone involved in health and care – public, patients, clinicians, NHS managers, and politicians – towards the role of clinical trials in society.”

The report emerged at the same time as the government unveiled a £650 million ($802m) drive to support the UK’s life sciences sector, including £121 million for the improvement of commercial clinical trials.

“Lord O’Shaughnessy is right that making the UK an attractive destination for industry clinical trials requires regulatory reform, speedier study set-up and approvals, and improved access to data,” said ABPI's chief executive, Richard Torbett.

“Implementing his proposals […] can be a springboard to delivering on the UK’s ambition to be a science superpower, and we now must press forward with delivery at pace.”