A global Novartis trial being supported by the Primary Care Research Network has offered a useful insight into how effective communication within the North West Exemplar is helping to quicken the set-up of research studies. The study, a chronic obstructive pulmonary disease (COPD) multi-site trial, enrolled the first global patient at the Layton Medical Centre in Blackpool. There were only 45 days between the study being submitted to CSP and the first patient being enrolled.
Blackpool is part of the Cumbria and Lancashire Comprehensive Local Research Network (CLRN) and one of eight UK sites that took part in the trial. There are 25 CLRNs that cover the whole of England and a key part of their role is to oversee the regulatory process by which studies accepted onto the NIHR Clinical Research Network Portfolio gain permission from NHS organisations to go ahead at individual sites.
The CLRNs use the NIHR Coordinated System for Gaining NHS Permission (CSP) to facilitate trial set up. At the heart of CSP stands the principle that there are some research governance checks that you only need to do once for multi-site studies, for example ensuring that a study has approval from a Research Ethics Committee (REC). These are known as global checks. Historically, global checks had to be carried out at each site involved in a trial, resulting in massive duplication, but because of CSP they now only need to be done once. Checks that are specific to individual sites, such as contracts and support service feasibility are referred to as local checks, and are carried out for each site.
The Cumbria and Lancashire CLRN Research Management and Governance Manager, Jill Martin, had the role of overseeing NHS Permission for the Novartis COPD study and feels CSP is helping Comprehensive Local Research Networks maintain clear lines of communication with each other and with industry partners,
“CSP has made a significant difference to multi-site trials because it enables all sites involved to see how global and local checks are progressing. We can all see what has been approved and, if there is a delay, we can see what is causing it. This means individual sites do not need to waste time chasing each other or the pharmaceutical company for information.”
For Vicky Brook, Clinical Project Manager at Novartis Pharmaceuticals UK Limited, having a lead network to oversee the study made communication much easier,
“What made taking part in the Exemplar stand out was that, in terms of liaising with the Comprehensive Local Research Networks, I only needed to speak to Jill. In the past no single network took responsibility for NHS Permissions and we had to field communications from a range of different people across the country. But in this instance, Cumbria and Lancashire led the project and Jill was always available to update us or update CSP. She turned the global checks around very quickly and the attention she was able to give to the study helped us achieve the first global patient enrolment.”
