This summer the first treatment for a rare genetic condition, which affects about 3,000 people in the west, was approved for use. The new drug for Morquio A syndrome was developed through clinical trials at Central Manchester NHS foundation trust, with support from the National Institute for Health Research Clinical Research Network (NIHR CRN).
Dame Sally Davies, the Department of Health’s chief medical officer, describes how the trial needed effective partnerships between patients, their families, clinicians, researchers and industry. She says: “This is an excellent example of how the NIHR is providing the best possible environment for health research in the NHS.”
Since 2006 the NIHR has been the research arm of the NHS in England, replacing ad hoc funding programmes managed by the Department of Health. And statistics released by the NIHR Clinical Research Network for 2013/14 indicate that it is helping to bring about some significant improvements in the levels of NHS participation and the timeliness of commercial clinical trial delivery.
The figures show over 600,000 NHS patients took part in studies in 2013-14, with those recruited to commercial studies up 26% to nearly 25,000. Most trusts – 86% – are now engaged in commercial contract research and its 15 local clinical research networks supported more than 900 commercial contract studies, an increase of 31% on the previous year and a 10-fold increase on 2008/09. The statistics also reveal that the time taken to set up commercial contract studies was halved in 2013/14 to an average of 26 days.
So how was this achieved? Clare Morgan, the NIHR Clinical Research Network’s clinical research delivery director, points to a two-year service improvement programme in which the network shifted its focus from providing services to the life sciences industry to providing what that industry wanted. “We turned it on its head, and that was very much the driver for the review and the implementation of a new service offering that we introduced 18 months ago,” she says.
She describes how the new service operates on three levels: first, early engagement with research companies when they are considering setting up a study; second, providing comprehensive feasibility for studies; and third, identifying additional research sites based on data about which organisations are best suited to particular studies.
Roger Newbery, vice-president for Europe, Middle East and Africa at PPD, says the network is making a “massive difference” to his company’s work. “We use them because they have put in a whole infrastructure of research support [in England] … And the most important thing for me is that they have added accountability for delivery [to NHS sites].”
Graham Oakley, clinical operations manager at Boehringer Ingelheim, says the network helps him project manage studies well, allowing the company to “recruit required patients, and they enable us to overcome any logistical issues on the journey, which could be anything, from a research nurse going off sick, to a site moving location.”
For NHS patients, participation in clinical research brings early access to “cutting edge treatments and technologies”, according to Morgan. One example is the StarT Back trial, which was supported by NIHR CRN: Primary Care and tested an electronic tool to help doctors identify patients at risk of long-term back problems. More than 850 patients across 10 GP surgeries took part in the trial The tool is now being implemented more widely across the health service.
From a base at Queen’s Medical Centre in Nottingham, Daniel Kumar manages the delivery of NIHR: East Midlands’ commercial clinical research. “Historically it used to be that sites would take a study, get it set up and then think ‘how do we deliver this bit of it, or that bit of it?’. I think part of our role is loading that upfront, doing the feasibility and predicting everything at the start.”
Being part of a regional network gives him an oversight of resources: “So we can say, ‘let’s use that cancer research nurse who is not so busy one day a week to help support that study in cardiology.’” The most rewarding aspect of his role, he claims, is helping sites, such as mental health trusts, that have never previously undertaken commercial trials to set up the necessary resources. “That is really satisfying, especially with the Dementia Challenge, which is a key area within the East Midlands, certainly.”
The NIHR Clinical Research Network is currently supporting about 3,000 studies, according to Morgan, which range from observational studies to randomised controlled trials of drugs or devices. In terms of developing its services, she believes the organisation must evolve to make more use of informatics, and to support the delivery of research according to the personalised healthcare agenda and stratified medicine.
Newbery believes the NIHR is unique and that there is no other government body with the raison d’etre of promoting such a wide spectrum of clinical research. So what should the organisation should do next? “I guess more of the same. What they have driven is a hunger for taking part in trials,” he says.
Content on this page is paid for and produced to a brief agreed with NIHR Clinical Research Network, sponsor of the clinical research zone.
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