The advent of precision medicine will require the NHS to set up new services to test patients for the biomarkers associated with these treatments – but if labs and hospitals gradually set up these services themselves, it could lead to duplication of effort and variations in services for patients.
To try and avoid this Cancer Research UK (CRUK) has set up the Stratified Medicine Programme, in partnership with pharma companies and the government's Technology Strategy Board, to push towards centralised, standardised testing and quality of access for patients.
"We're trying to make sure we have one system that's got rigorous QC and QA, and that we open that system up to as many patients as possible right across the UK," says Rowena Sharpe, CRUK's head of precision medicine, who leads the programme. "We have about 70 NHS trusts that have sent patients and samples in, and three centralised labs that do the testing.
"Those tests determine whether a patient is eligible for a large 21-arm clinical trial called the Lung Matrix Trial, which tests various combinations of biomarkers and drugs. That's teaching us a lot about how to do genomic screening. We've also got initiatives in colorectal cancer and breast cancer."
One of the reasons for setting up the Stratified Medicine Programme was to demonstrate the advantages of national prescreening over local labs.
"If you run a study in just a single centre it's easier to control the process and quality," says Sharpe, "but your referral network to that centre will be severely limited, and therefore the patients that get access to it is reduced.
"If you have a larger network then you get more patients in and you retain the high quality of testing. You have a limited number of labs, they just have a large number of samples coming to them.
"We want to have multi-centre studies and make our studies as equitable as possible. One of the reasons for developing the Stratified Medicine Programme is that when our targeted therapies first came on the market we didn't have equity of access, and that gap still remains to a certain extent, but the NHS is working hard to provide the funding and support to make sure that there is access to the test for patients who need it."
Sharpe adds that the programme has taught CRUK a lot about how to communicate with patients about precision treatments.
"We need to make sure that we inform our patients at the start of the process so that they understand fully what they are signing up to. The more that our patients understand, the better.
"It's also really important that we only give them the information that they need to hear and that's relevant to them at that point in the process. Because we've added in this extra testing step which may be followed by lots of different trial interventions depending on the patient's genomic makeup, we've taken the approach of splitting that consent into two phases.
"First we approach the patient and say 'We will test a bit of your tumour, are you happy for us to do that?'. If they go on to have a positive result they will be approached again by the clinical team to say, 'This is your result and it makes you eligible for this targeted therapy'. Then they can talk through that intervention in more detail rather than saying up front 'You could go into one of 21 arms of a clinical trial'. That's just too much information."
See our upcoming September issue for a wider look at the challenges in implementing precision medicine across the UK