An NHS choked by bureaucracy is losing ground-breaking clinical trials, and it needs to the private sector to help save its reputation, writes Elena Siniscalco
In the UK, we are so used to having highly efficient, easily sourced drugs at hand. We’ve taken for granted the ease at which these drugs are made, who approves them and how they enter the market and eventually end up in our bathroom cabinets.
When clinical trials are run in the UK, either through the NHS, or now more frequently through private firms, we gain the pharma companies’ investment in our R&D infrastructure; we gain new drugs, often at a discounted price; we gain precious data on the illnesses and conditions that run through our society.
When clinical trials aren’t run in the UK, we lose out on all of this; and losing we are indeed. The number of industry clinical trials started in the UK each year has fallen by 41 per cent between 2017 and 2021.
There are different reasons for this. The NHS is slow, choked by bureaucratic hurdles and delays. Lord James O’Shaughnessy recently led a review into clinical trials, and said that one big pharma company told him that of 18 places in Europe where it did one of its trials, the UK was the second slowest one.
Often when trials are run in hospitals, the data is not centralised and “no one knows who’s doing well and who’s not”, according to O’Shaughnessy. Overworked clinicians and nurses don’t get involved in trials as there’s no incentive for them to do so.
Private companies have found a market gap to fill. Lindus Health, one of them, uses technology and machine learning to run entire clinical trials. Their pitch is all about affordability. Big pharma spends billions of pounds on trials, and then passes on the costs to the customers, indirectly or directly through more expensive medicines. If the trial costs less, the drug costs less.
Lindus has shiny offices and a young team of professionals. They’ve developed their own software to run the trials; everything is automated, from emails to reminders to take specific medications. All of the data is easily at hand to see what works and what doesn’t.
They mock-enrol me in one of the trials they’re currently running for type 2 diabetes. It involves a call with their nurse and signing a consent form online. It takes less than half an hour. Lindus says it can usually sort out recruitment and regulatory approval and start a trial in 2 to 4 weeks while through the NHS, it can take from three to six months.
On top of digitalisation, the other smart move is running parts of trials that can’t be done remotely in primary care settings. This solution is at the core of O’Shaughnessy’s review: if a patient has to take a blood test, why does it have to be in a hospital? It could easily be done by a GP or in a pharmacy.
Lindus partners with private clinics, and patients seem satisfied. Kevin, who goes to the clinic in Victoria, said: “It doesn’t strike me as a massive inconvenience and it serves a good purpose.”
Certainly the NHS has a lot to learn from how Lindus executes its trials, and a lot to lose in the form of investment from pharmaceutical companies who are choosing to go elsewhere. According to Jennifer Harris, Director of Research Policy at the Association of the British Pharmaceutical Industry, clinical trials account for “about 50 per cent of investment in R&D from medical companies”. Pharma companies pay the NHS for each stage of the trial, including the first, research-heavy ones. The benefits of this research go far beyond the trial itself, making the NHS a healthcare system people want to work for as they know they could be doing research on groundbreaking new treatments.
Lord O’Shaughnessy has an almost utopian vision for the NHS’ relationship with clinical trials, a world where expertise and funding are brought back into the regulators to cut down the backlogs of approving the trials, recruitment is swifter, parts of the trials are run not in hospitals but in communities and data is centralised and analysed efficiently.
The government has promised £121m to speed up clinical trials. But we all know how long even minor reform in the NHS takes.
A second scenario would join up the public and private sector and divide the tasks. The public sector, with world-class university researchers, could lead on the first stages of a trial; the private sector could take care of the last ones. “One of the most important things for a pharma company deciding to invest in a country for clinical trials is knowing that every stage lines up in the process”, says Patrick King, a researcher at Reform.
If the best way to achieve that is through cross-sector collaboration, maybe that’s the way forward.