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The University of Oxford's International Subarachnoid Aneurysm Trial (ISAT) changed clinical practice worldwide by showing that endovascular coiling is a more effective and safer treatment than neurosurgery following subarachnoid haemorrhage, with fewer complications and improved quality of life. Subarachnoid haemorrhages account for 1 in 14 strokes and are caused by bleeding in and around the brain; approximately 85% occur when cerebral aneurysms rupture. ISAT was the first trial to compare neurosurgery, or neuroradiological endovascular coiling in patients with ruptured cerebral aneurysms causing acute subarachnoid haemorrhage.
This case study summarises a body of research on Multiple Sclerosis (MS) developed at Plymouth University under the leadership of Professor Zajicek and Professor Hobart. Hobart's work on linical outcome measurements has directly influenced clinical research, trials and drug licensing, especially in MS and Alzheimer's disease. The MS scales developed by Hobart have been endorsed by the United States FDA and are in demand by commercial organisations in the development and trialling of treatments for MS and have led to the licensing of new drugs. Zajicek has led the topical field in evaluating the potential benefits and risks of cannabis for treating MS, contributing to the evidence base behind the medical use of cannabinoids in general, and pioneering its global potential use to slow neurodegeneration.
Prior to the change in WHO recommendations which occurred following this study many patients in Africa and other developing countries were receiving an inferior regimen for the management of tuberculosis, a consequence of which meant that many had to be retreated. Since the implementation of the revised WHO Guidelines in 2010 almost all countries have now switched to the gold standard tuberculosis treatment regimen based on 6 months of isoniazid and rifampicin
Starting from a mechanism-based hypothesis, Alastair Compston and colleagues in Cambridge have led the academic development of Alemtuzumab as a highly effective therapy for relapsing-remitting multiple sclerosis through Phase 1, 2 and two Phase 3 trials (1991-2012). The impacts to date are demonstration of the importance of the therapeutic `window of opportunity' in treating multiple sclerosis; a product licence in the European Union (September 2013) for the commonest potentially disabling neurological disease of young adults; expansion of the work-force in industry to develop and market this initiative; and an estimated several-fold increase in revenue to the University of Cambridge (and other beneficiaries) from total royalties of £18.6M from 1997 to date.
Researchers at the Dunn School of Pathology at the University of Oxford have played a major role in the development of an effective and innovative treatment for the chronic debilitating disease multiple sclerosis (MS). Research arising from the work of immunologists in Oxford, and partner neuroscientists in Cambridge University, has shown that low dose treatment with the lymphocyte depleting antibody alemtuzumab can break the cycle of disease in MS. Alemtuzumab acts by re-setting the immune system, leading to long-term arrest or remission, without increasing the risk of infection or malignancy. Large-scale studies since 2008 have shown that treatment is more effective and better tolerated than conventional forms of therapy. In June 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that the drug be licensed for people with active relapsing-remitting MS. The research by Oxford University and its collaborators into the use of alemtuzumab in MS has been shown to benefit patients; it offers hope to millions of sufferers worldwide; and has had a major impact on the pharmaceutical industry.
Clinical trials are costly to the pharmaceutical industry and public funding bodies, require major commitment from volunteer patients and take significant time to lead to patient benefit. Adaptive designs are one approach which seeks to improve the efficiency of such studies. Statistical research at Reading has led to novel methodology for the design and analysis of clinical drug trials within the framework of adaptive designs which has the potential to reduce the time taken for effective drugs to reach the market and thus benefit specific patient groups. To date the research has had impact in three major ways: i) it has been adopted by pharmaceutical companies as a means of improving the efficiency of their clinical trials, ii) the research has been cited in the regulatory guidance on adaptive clinical trial design, and iii) it has increased awareness by clinicians and other medical professionals of the potential benefit of the adaptive design methodology to their patient groups. Hence, the research has influenced industry, regulatory and health professionals with potential significant economic benefit and improved outcome for patients.
Neonatal extracorporeal membrane oxygenation (ECMO) is a complex procedure of life support used in severe but potentially reversible respiratory failure in newborn infants. In 1993 researchers in Leicester carried out the first and, to date, only large-scale randomised trial comparing the value of ECMO with other means of life support. The trial, with follow-up research at 4 and 7-year intervals, has shown ECMO to be a life-saving and cost-effective treatment, and has led to the establishment of a centrally funded neonatal programme that is estimated to have saved around 340 lives in the UK alone. In 2013 the University remains internationally renowned in the field of ECMO research, and since 2009 Glenfield Hospital has been home to the world's largest ECMO centre for the treatment of newborns, older babies and adults. The trial is still held up by advocates of fair clinical trials as an example of how evidence should translate into practice and policy.
Nottingham researchers constructed the world's first 3T MRI scanner, thus demonstrating the viability and benefits of high-field MRI. This provided a stimulus for magnet and MRI system manufacturers to develop 3T scanners, which have now become established as the standard platform for high-end clinical MRI studies. We estimate that since 2008: 2500 3T scanners have been installed, representing a global investment of $5 billion;and 30-40 million patient examinations have been performed with 3T MRI scanners. Technical advances which underpinned the Nottingham 3T scanner also impacted on the development of functional MRI, thus opening up a new field of medical research and clinical application. In a subsequent phase of research, the Nottingham group developed ultra-high (7T) magnetic MRI in partnership with PhiIips; forty 7T MRI scanners (current unit cost >$10M) have now been installed across the world.
By identifying a novel approach to treat allergy and autoimmune disease the University of Bristol has created a new field of research into antigen-specific peptide immunotherapy. Initial work carried out by Professor David Wraith at the University has since 2008 led to the creation of new businesses, (including the spinout company Apitope), generated 100s of millions of pounds of investment and underpinned both the adoption of new technology and the development of new products by the pharmaceutical industry. The commercial impact of this research into antigen specific immunotherapy is on-going and expanding.
Sustained research by the University of Oxford's Mahidol Oxford Tropical Medicine Research Unit in Thailand (MORU) has been the driving force behind the current World Health Organization recommendations for the management of acute and chronic infection in patients with melioidosis. This research has motivated improvements in treatments and provided new strategies to identify at-risk populations, enabling clinicians to make early diagnoses. Melioidosis is a major cause of severe illness in parts of Southeast Asia and there are increasing numbers of cases in India, China, and Brazil.