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Doses of cytotoxic drugs for chemotherapy need to be determined on an individual basis for each patient and are generally calculated using Body Surface Area (BSA). Traditionally, this meant that doses of cytotoxic drugs needed to be prepared at `the bedside', resulting in safety issues, significant wastage and placed an enormous burden on the time of healthcare workers. `Dose-banding' is a system whereby chemotherapy doses, calculated using BSA or other means, are then fitted to pre-defined dose ranges, or `bands'. This system allows for `standard' syringes or infusions to be batch-prepared by the hospital pharmacy, or even pre-prepared and purchased from an external commercial source.
Research at the University of Bath, conducted between 2000 and 2007, pioneered the establishment of dose-banding as a practice and, through its spin-out commercialisation vehicle, Bath Aseptic Services Unit, Ltd. (Bath ASU), demonstrated that the batch production of cytotoxic drugs according to dose-banding is a viable commercial proposition.
Today, dose-banding is accepted around the world as a valid method of dosing cytotoxic therapies and, since 2008, has had a profound economic and social impact on the healthcare sector through improved patient care, changes to purchasing policy and improved health outcomes. In fact, the impact of dose-banding is so significant in the UK that NHS cancer trusts now recommend that dose-banding should be implemented to manage capacity before investing in staff and facilities.
Bath ASU now supplies over 150 NHS hospitals and pharmacies with upwards of 500,000 doses of injectable `specials' per year (supplying around 30% of the entire UK commercial compounding market), employing over 70 full-time staff and currently generating revenues of over £20M per year.
Warfarin is an anti-coagulant drug prescribed to tens of millions of people in the UK and US who are at high risk of developing blood clots. Because individual sensitivity to warfarin varies in the population there is a risk of overdosing the drug and causing serious bleeding and even stroke in many people when starting treatment. In 1999 researchers at Newcastle University were the first to demonstrate a statistically significant link between a person's genotype and the appropriate dose of warfarin. In 2010 the US Food and Drug Administration (FDA) mandated inclusion of a table of dose recommendations based on genotype in the warfarin prescribing information leaflet accompanying the drug. Newcastle research forms the basis of the 2009 international standard algorithm for gene-guided dosing of warfarin. This approach has been adopted by large US medical centres and the FDA states that it will prevent 17,000 strokes a year in the US.
The Cancer Research UK Formulation Unit at the University of Strathclyde performed the pharmaceutical research and development of new chemotherapy treatments for malignant brain and prostate cancer (temozolomide and abiraterone acetate). These two drugs are now marketed globally, with FDA approval for the US market in 1999 and 2011 respectively, and have directly improved the quality of life and increased survival rates during treatment for over a quarter of a million cancer patients annually since 2008. Temozolomide achieved $1 billion sales per annum in 2008, and Abiraterone global sales reached $1.45 billion by 2013. Both drugs have produced economic benefit to the charity Cancer Research UK through royalty payments.
Clinical pharmacology studies conducted at Newcastle have led to optimisation of the administration of the chemotherapy drug carboplatin in children with neuroblastoma and other cancers. The research provided the rationale for carboplatin dosing based on patient renal function, with individualised dosing resulting in increased drug efficacy and reduced toxicity. This approach is now in widespread use in national and European treatment protocols, benefitting over 2,500 children. Similar drug monitoring approaches are being implemented for an increasing number of important drugs. Following a recent Newcastle-led national clinical trial, new dosing guidelines for the drug 13-cis retinoic acid have been adopted for high-risk neuroblastoma patients across Europe.
As part of a 20 year partnership with AstraZeneca, Professor John Robertson, University of Nottingham, has made the largest and most consistent contribution by a clinical academic to the development of the most recent endocrine agent licensed for breast cancer, fulvestrant (Faslodex®). [text removed for publication]. Since 2008, fulvestrant 250mg has continued to be registered and launched in a number of countries based on Robertson's work, and Robertson has enhanced the clinical uptake of fulvestrant 250mg through training. His research has also been instrumental in the development and uptake of the more efficacious fulvestrant 500mg, including registration in 2010.
The PCI is a carefully designed Head & Neck (H&N) cancer pre-clinic consultation checklist and comprises aspects of care and outcomes that patients might wish to raise with the multi-professional healthcare team. The PCI is an innovative and effective tool whose development has been optimised for touch screen devices. (Full details on use of the PCI is given at http://www.patient-concerns-inventory.co.uk/PCI/Home.html.) The PCI has improved patient experiences of clinic consultations, helped development of quality indicators and improved professional practice. The impact of the programme of work has led to its wider implementation nationally as exemplified by its adoption by the British Association of Head and Neck Oncologists (BAHNO), its inclusion in the National H&N Cancer dataset, its emerging use internationally, and its development in other chronic conditions.
Research conducted by a multidisciplinary team of oncologists and scientists at the University of Southampton has driven major advances in lymphoma care, leading to the development and standardisation of effective new antibody treatments and optimal drug regimens. Through their direction of international clinical trials, they have influenced care for Hodgkin and Burkitt lymphoma in the UK and internationally, affecting all stages of patient-experience from diagnosis to treatment. Their findings underpin significant improvements in survival and quality of life for the 14,000 people affected by lymphoma in the UK each year.
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.
University of Glasgow research has led to the adoption of first-line chemotherapy for ovarian cancer, which has improved patient survival by 11% and has been used to treat 66% of women with ovarian cancer since January 2011 in the West of Scotland Cancer Care Network alone. These therapies are recommended by guidelines for ovarian cancer treatment in the USA, Europe and the UK. The USA guidelines are disseminated to 4.3 million people worldwide and the European guidelines reach 15,000 health professionals. The UK guidelines are used to identify those drugs that are funded by the NHS and used in NHS hospitals.
This research has improved the clinical use of powerful antibiotics. New guidelines for vancomycin use in adults have been adopted by the NHS throughout Scotland and in other parts of the UK. New neonatal vancomycin guidelines have decreased the time to achieve optimal antibiotic concentrations and reduced patient trauma and staff workload. These guidelines are used routinely in the Greater Glasgow area and other parts of the UK. Tobramycin guidelines improved the management of infection in patients with cystic fibrosis in the Glasgow and Edinburgh areas. Additional studies, which investigated guideline implementation across NHS Scotland, resulted in nationally supported resources designed to improve the quality of patient care when vancomycin or gentamicin is used.