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Clinical trials form a crucial step in translating fundamental medical research into improved healthcare. Many hundreds of trials are conducted every year, each involving hundreds, sometimes thousands, of patients. These trials are expensive, with costs as high as 20 or 30 thousand pounds per patient. Research in Bath on group sequential monitoring and the adaptive design of clinical trials has improved the conduct of clinical trials, leading to:
The impact of this research is economic (the business performance of pharmaceutical companies and businesses that support them), societal (by enhancing public health and by changing the policies adopted by regulators) and ethical (ensuring clinical trials remain safe, while bringing life-saving treatments into clinical use as rapidly as possible).
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.
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
Dr Jeremy Howick's research into philosophical issues concerning the nature of the evidence invoked in evidence-based medicine has led both to a revision of the standards for reporting trials, and to a redesign of the Oxford Centre for Evidence-Based Medicine `Levels of Evidence': one of the most widely used systems for ranking medical evidence, and thereby for deciding whether treatments are effective, in the world. His research into philosophical issues concerning the ethics of using placebos in clinical trials and in clinical practice has influenced practitioners as well as patients by helping to determine how treatments are developed and applied. Through his research in both of these areas he has enhanced public understanding of the use of placebos.
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.
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.
Professor Hutton's research considers the biasing effect of selection of data due to consent procedures or selective reporting, and its consequences for the validity of conclusions and reliability of results. This research has had impacts on patients directly; on health and legal professionals by informing and influencing national and international guidelines for the treatment of epilepsy used by healthcare professionals and practitioners; and has provided expert evidence to legal professionals for the conclusion of civil litigations and a General Medical Council professional misconduct trial. Hutton's research also informs ethical debate associated with the validity and robustness of study results. This work has determined guidelines for ethical conduct of research, and requirements for publications, which are significant for all biomedical researchers.
Research on professionals' discussions about clinical trials of cancer therapy has identified the major barriers to patient recruitment to clinical trials. This research was used to create an educational intervention to improve patient experiences and willingness to participate in a variety of clinical trials worldwide, resulting in increased participation in prostate, colorectal, renal and breast-cancer trials. It also involved educating members of UK cancer teams to the best ways to approach, communicate and maximise trial planning.
Bowel cancer is the third most frequently diagnosed cancer worldwide. University of Glasgow researchers have established Xeloda (an oral 5-fluorouracil precursor) and XELOX (a chemotherapeutic regimen combining Xeloda with oxaliplatin) as highly effective, targeted therapies for patients with bowel cancer. Since 2008, European regulatory approval of these therapies has been incorporated into major international clinical guidelines. The research has transformed patient care by improving the treatment experience, with more convenient dosing schedules and fewer side effects compared with previous chemotherapy procedures. Xeloda and XELOX have transformed chemotherapy for bowel cancer and decreased therapeutic costs, potentially saving around £4,762 (Xeloda) and £947 (XELOX) per patient for the NHS.
Patients in clinical trials tend to have a very high drop-out rate which compromises results. Research by Sarah Edwards provided the key ethical framework for limiting individual choice in designing research involving human subjects. Edwards' research, showing how such designs can legitimately limit individual choices to withdraw, was incorporated into guidelines in the UK, Canada and the US, and by international bodies such as the World Health Organisation. In the UK, the research was also used to develop guidelines for ethics committees approving controlled trials.