The National Institute for Health Research Clinical Research Network (NIHR CRN) has struck a blow for the UK’s competitiveness as a base for international clinical trials by recruiting the first two global patients in a commercial study of an investigational cancer drug.
Enrolling a first global patient is a key performance indicator for the life-sciences industry in clinical research delivery, as it shows the UK has the necessary infrastructure to support rapid set-up of clinical studies, the CRN noted.
The trial in question is being run by US-based life science company Verastem and is the first study Verastem has placed in the UK.
It is a pivotal clinical trial of the FAK inhibitor VS-6063 in malignant pleural mesothelioma, a rare cancer affecting the lungs and an area of high unmet clinical need.
The study design will also characterise and stratify patients on the basis of a biomarker with potential to predict sensitivity to FAK inhibitors such as VS-6063.
The first global patient was recruited by principal investigator Professor Dean Fennell at Leicester Royal Infirmary, with the second following shortly afterwards at the same site.
NIHR CRN quoted an unidentified Verastem spokesperson as saying the UK had been “by far the most efficient and speedy” of the 11 countries in which the VS-6063 trial is taking place.
According to Sue Zanker, project manager at contract research organisation TMC Pharma Services, which is overseeing local delivery of the study, the UK has “just made a complete change in terms of clinical research”.
The Clinical Research Network’s systems “worked well for us and expedited the applications and R&D approvals process”, Zanker added. “This gave us a head start on other countries”.
The NIHR CRN has achieved 20 first global patients in total since April 2013.