“By putting in place expert infrastructure and a range of streamlined research processes the UK has been able to focus on reducing study start up times and ensuring better delivery, leading to more cost effective studies.” (Mark Samuels, Managing Director, NOCRI)What are the main advantages of working with NOCRI? The NIHR Office for Clinical Research Infrastructure (NOCRI) simplifies access to the United Kingdom’s clinical research infrastructure. This includes working with UK’s best clinical investigators, in world-class facilities, with access to well characterised groups of patients within the 60 million people who use the National Health Service in the UK. As a unique resource for the global life sciences industry, NOCRI improves the quality, efficiency and success of translational research by providing rapid connection to expert investigators, cutting edge technologies and a managed process for collaborative research. The team is focused on successful outcomes – from making rapid introductions through to supporting collaborations to ensure delivery. NOCRI provides connections to the most eminent experimental medicine experts who help companies understand the potential of their developmental drugs, devices and diagnostics, to shorten cycle times and enable earlier go/no go decisions. Rapid links to the NIHR’s Clinical Research Network also provides for the efficient and effective delivery of larger and multi-centre clinical studies. What are some of the reasons companies and researchers from outside the UK overlook the UK when choosing a place for clinical research? The UK has always had a strong basic science base and the expertise to translate discoveries from the laboratory into the clinic. Over recent years the Government, through the NIHR, has continued to strengthen this research capacity through increased investment and by establishing research infrastructure that supports the flow of innovation from the laboratory to the patient. This expertise is embedded within the National Health Service, which serves a population of over 60 million people, and within the country’s leading universities. This creates an ideal environment to carry out cutting edge, patient-centred research. When you add in the streamlined and rapid access to the country’s expertise provided by NOCRI, any misconceptions about the UK being a complex research environment in which to work are easily dispelled. How do the costs of working in the UK compare with doing trials elsewhere? The UK has focused on quality and cost effectiveness in clinical research. By putting in place expert infrastructure and a range of streamlined research processes the UK has been able to focus on reducing study start up times and ensuring better delivery, leading to more cost effective studies. How have recent changes in the clinical research and regulatory landscape in the US (FDA) and Europe increased the opportunities for conducting trials in the UK? The UK Government is committed to creating the right conditions for businesses to succeed, removing barriers that are preventing them from performing to their full potential. They have highlighted that health research has a key role in the national economy and that a thriving life sciences industry is critical to the ability of the NHS to deliver world-class health outcomes. A recent example of one of these positive changes is the establishment of the Health Research Authority which will benefit patients, the research community and the life sciences sector by simplifying and streamlining the regulatory processes associated with health and care research. The impact of these developments is making the UK an increasingly attractive destination for clinical research. What would be some examples of clinical trials carried out by small companies or universities from outside the UK in both the drug/biotech and medical device/diagnostic areas? What advantages/ benefits did they obtain by working in the UK? The NIHR Moorfields Biomedical Research Centre is due to begin conducting trials of an experimental treatment that may offer hope to young people suffering from a currently untreatable inherited eye condition. The trials of technology developed by US company Advanced Cell Technology (ACT) will investigate the safety of using retinal cells derived from stem cells to treat people with advanced Stargardt disease, a form of macular degeneration that causes disabling loss of sight in young people. The cells will be injected into the retina during an operation lasting up to an hour. This is a great example of how external investment for world-leading research is being attracted to the UK, through the targeting of the world-leading science, world-class facilities and the country’s best investigators with access to well characterised groups of patients within the 60 million people who use the National Health Service in the UK. Based on a novel industrial partnership with the Swiss-based SME Santhera Pharmaceuticals, the NIHR Newcastle Biomedical Research Centre delivered the first treatment trial for mitochondrial disease, showing potential for the drug idebenone in the genetic eye disease, Leber hereditary optic neuropathy. Following this, NIHR Newcastle Biomedical Research Centre successfully applied to the for a Phase II clinical trial using the agent in a genetically defined sub-group of patients, thus forming the first stratified medicine study in rare mitochondrial diseases. The NIHR Newcastle Biomedical Research Centre underpinned the application and study design through the mitochondrial theme, and also through core statistical and trial design support. The cardiovascular team at the NIHR Imperial Biomedical Research Centre, in collaboration with US-based medical technology company, Volcano Corporation, is devising the instant wave-Free Ratio (iFR) method to enable measurement of blood pressure on either side of a narrowed artery without the need to use pharmacological vasodilators as in the conventional fractional flow reserve (FFR) technique. This is an improved diagnostic technology that is more time-and cost-effective than the FFR method and is likely to alter clinical practice. The outcome of the pilot study on 131 patients has produced highly reproducible positive results. How many clinical trials were conducted in the UK in 2011? During 2011 a total of 713 commercial clinical trial applications were made to the UK’s Medicines and Healthcare products Regulatory Agency. In 2011-2012, the National Institute for Health Research Clinical Research Network helped to engage NHS patients in more than 3,500 studies, with almost 600,000 patients taking part. Of these, nearly 500 were commercial studies conducted on behalf of pharma, biotech and med-tech companies. How many trials has NOCRI helped coordinate? Since its formation in 2010, NOCRI has focused on linking a wide range of Pharma, BioTech, MedTech and diagnostics companies with expert researchers and research facilities across the country. During this time NOCRI has worked with companies and UK researchers on over 45 potential research studies. When was NOCRI founded? How many people work there? NOCRI was established in early 2010 with broad coordination role for the NIHR’s infrastructure of over 3,000 research staff embedded in the UK’s National Health Service. NIHR infrastructure has a key priority to support collaboration with industry and, as opportunities for bringing industry and expert researchers together have increased, the core NOCRI team has gradually expanded to 12 people. The NOCRI team works closely with a range of organisations including research funders, charities, and Government Departments, to help ensure that the UK research environment is coordinated in its approach to partnership with industry.
NOCRI: Easy Access To Clinical Trials In The UK
“NOCRI has simplified and streamlined access to the UK’s world-class clinical research infrastructure,” says Mark Samuels, explaining why an increasing number of companies from around the world are conducting their clinical trials in the UK.
On Nov. 7-8 a delegation from the NIHR Office for Clinical Research Infrastructure (NOCRI) will provide in Israel a two-day seminar and work-shop, followed by 1:1 meetings with selected companies . To participate contact Iris Geffen Gloor, Biomed Manager, UK Israel Tech Hub@ The British Embassy in Israel iris@UKIsraelHub.com
NOCRI’s Managing Director Mark Samuels, in an interview with BioIsrael, describes why the UK can be the most cost-effective place for Israeli companies to conduct both drug/biotech and medical device/diagnostic trials. He notes that the new option of working through NOCRI has attracted more and more companies from outside the UK. Foreign companies conducting commercial studies in the UK include Advanced Cell Technology (US), Santhera Pharmaceuticals (Switzerland) and the Volcano Corporation (US). In 2011-2012 the NIHR Clinical Research Network supported more than 3,500 studies involving over 600,000 patients.