Published: 12 March 2019
“The past is a strange country: they do things differently there...” wrote L.P. Hartley in ‘The Go-Between’.
A national infrastructure to support clinical research in the NHS is not sufficient on its own to drive uptake and performance in clinical trials. It requires guides to help navigate the landscape and deliver service users to their required destination. It depends upon facilitators to explain the system and interpret the rules of engagement. It needs an honest broker to bring together the experts, stakeholders and users to ensure all sides get the best outcome possible. At the #DIAEurope2019 meeting in Vienna in February the ‘Will patient involvement improve clinical research’ session provided great examples of the need for a go-between function.
In the past the idea of life science companies involving patients in the design and improvement of clinical protocols was unheard of. However, even as companies became aware of the growing need to engage patients in study design, and #PatientCentricity became the new conference buzzword, they were not really sure of how to go about identifying suitable patient groups, making the required links, or developing best practice procedures around involving patients.
During the session at DIA, the European Patients Academy (EUPATI) and the NIHR both gave solid examples of the methodology behind patient engagement, and provided practical examples of how this works in practice. Common to both examples was the need for a trusted organisation to inform patients about the benefits of engaging with an industry that previously some may have been wary of. This has been achieved by working in partnership with patients to develop the guidelines on how the engagement would take place and by providing the appropriate support and training for all involved.
The NIHR’s Patient Engagement in Clinical Design workstream was created with patient input from the outset and allows patient groups to engage with life science companies in a safe environment, under the honest brokerage of the NIHR, and with minimal bureaucracy. From the company perspective the NIHR can provide introductions to patient groups in whichever therapy area they require and provides a pre-agreed framework and standardised agreement to make the process as quick and simple as possible. The result is a win-win for all concerned - less protocol amendments post approval, a more positive experience for patients participating in the trial, and ultimately quicker clinical trials meaning reduced time to get new medicines on the market.
The #SCOPE19 meeting in Florida also showed how far the life sciences industry has come in terms of joint working in recent years. It included examples such as the Transcelerate collaboration between the major global pharmaceutical companies working on joint initiatives such as the Shared Investigator Platform. However, the industry is still conservative when it comes to closer collaboration on the clinical trials themselves.
The session at #SCOPE19 regarding site selection is a good case in point. There were presentations from companies describing the methodology behind their site selection decisions. Data from many sources, algorithms, track records and the beginnings of applying AI all featured. But there was no mention of working together with other companies, or stakeholders, to make more efficient use of resources at site level in a non-competitive manner.
I described the NIHR Study Support Service and how, as a national network, the NIHR Clinical Research Network (CRN) has oversight of most clinical trials in all centres in England, both commercial and non-commercial... And explained that it’s here that a great opportunity is being missed.
While CRN is able to provide excellent feasibility, leading to great delivery of trials, (last financial year 74% of commercial trials closed on target within the agreed time), this is still on a company by company basis. The untapped benefit that CRN can bring, as an honest broker between companies, is in the co-placement of studies in centres or regions to make the most of the Network's screening efforts.
Let me give you a hypothetical example: CRN is approached by ‘Company One ’ to run a study in non-small cell lung carcinoma (NSCLC) in patients expressing the rare biomarkers ‘AB’ and ‘YZ’. The site needs to screen many NSCLC patients to find those who express those rare markers. This means that many other patients (not expressing those markers) are screened but not consequently offered an opportunity to participate. A month later the Network is approached by ‘Company Two’ who also have a NSCLC trial but for patients expressing markers ‘CD’ and ‘WX’. Different sites are selected this time and again many patients are screened to find the few who are eligible to participate in the study.
But what if those companies collaborated in the safe harbour of the CRN? What if Company One and Company Two opted to place their studies at the same sites and only ask the Network to screen NSCLC patients once, but for all four markers?
There is already some interest in this approach.
In the UK we have been running a number of academic studies that are paving the way for greater collaboration in the form of multi-arm multi-stage (MAMS) trials such as STAMPEDE, FOCUS 4 and LUNG MATRIX. Here we see different companies supplying drugs in the different stages of the same study. This level of collaboration is yet to be seen in the full commercial setting. Any volunteers?
The NIHR is your broker, your facilitator, your guide. We can help bring companies together to maximise the potential of the network approach while simultaneously offering more opportunities for NHS patients to gain access to cutting edge treatments through clinical trials. We hope that in the future years the past will not been seen as a ‘strange country’, and that instead the creation and growth of a national network to support clinical research in the NHS was seen as the turning point for greater collaboration, advances in medicine and increased patient benefit from clinical research.
Why not get in touch and find out what we can achieve together?
matt.cooper@nihr.ac.uk