ResearchNurses.co will conduct home visits in clinical trials for three Big Pharma firms after forging an agreement with Nottingham University Hospitals Research and Innovation Department.
Under the deal the UK firm will provide nurses for clinical trials of drugs for multiple sclerosis (MS). The team will work across all areas of the disease, from primary progressive to secondary, relapse remitting and secondary progressive. And as the alliance with Nottingham is a master services agreement, the firm could also supply caregivers for other studies.
Speaking to Outsourcing-Pharma.com, ResearchNurses.co MD John Illingworth said there has been a huge uptick in demand for outsourced clinical trial nurses, especially in the home care setting.
And though he was unable to name the three sponsors – saying only that two are pharmas, one is a biotech, and that: “They’re all big players ” – he did predict that there would be many more deals of this type as a result of new regulations.
“Without a doubt there is a rise in the number of home care nurses used in clinical trials, and a big reason is that the FDA have now said that if a device is going to be used in the home, there should be data in the home care setting,” said Illingworth, referring to the US Food and Drug Administration’s 2010 Medical Device Home Use Initiative.
"Worryingly," he added “I’m absolutely certain that there a number of people who aren’t aware that this is even in existence, who are presenting their data and being told to back.”
Illingworth also said there has been a rise in the number of paediatric studies being carried out since PIP (paediatric investigation plan) regulations came into force, which in turn has contributed to an increase in demand for nurse home visits. He told us the firm has just inked a major deal for paediatrics home visits for a major - but unnamed - pharma firm.
“Home care helps particularly in this area because there’s the issues of the parent having to take time off work to come with their child, or the child taking time off school,” he said. “In order to enrol patients into projects and retain them, you want to minimise the disruption caused.”
Illingworth also told us the increase in the number of trials for orphan and rare indications has also bolstered business because there are less sites offering treatment, and so often patients must travel further to get to them, therefore are more likely to drop out.
The outsourcing trend
Employing the services of research nurses from an external source could become more popular for financial reasons, Illingworth added.
He said it could fit well with a trend for contract staff from agencies in the industry, as it reduces the fixed costs incurred by sponsors and researchers.
“The nurse is on our books so the permanent costs are not associated with them,” he said.