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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.
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.
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.
Cardiovascular disease is a major worldwide health issue and cholesterol has long been recognised as an important risk factor. The Robertson Centre for Biostatistics (RCB), led by Prof. Ian Ford, has played a central role in establishing for the first time the benefits of statins in preventing first-time heart attacks in men, with subsequent major influence on medical practice and guidelines for patient care. Innovative record linkage techniques used by the RCB have identified the long-term benefits of treatment, confirmed safety, and quantified the economic benefits.
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
Trauma is a rapidly increasing global healthcare problem which is predicted by the World Health Organisation (WHO) to overtake infectious disease globally by 2020. The discovery of the acute coagulopathy of trauma (uncontrolled bleeding) and the subsequent establishment of the clot stabiliser tranexamic acid (TXA) as a treatment for this condition has led to a change in national and international trauma management protocols. British armed forces and the US military implemented the use of the drug soon after the results were published. Every injured British or American soldier now receives this treatment. The use of TXA has been included in national and international guidance for trauma care.
Patients are more likely to get the most effective healthcare, at affordable cost to the NHS, as a result of research methodology, developed by researchers at the University of Bristol, that allows the efficacy and cost-effectiveness of multiple treatment options to be compared, based on all the available evidence, much more efficiently than in the past. Since 2008, these methods have been used to inform Clinical Guidelines issued by the National Institute for Health and Care Excellence (NICE) and in submissions to NICE's Technology Appraisals. Guidance in NICE's Technology Appraisals is mandatory and therefore impacts directly on clinical practice. The methodology is used in decision making by NICE's equivalents in other countries including Canada, Germany, and South Korea, and by consultancy firms that conduct analyses for pharmaceutical companies.
The World Health Organization (WHO) estimate 3.3 billion people are at risk of malaria, with 219 million cases and over half a million deaths annually. The Liverpool School of Tropical Medicine (LSTM) has applied new methods of research synthesis to malaria, and the results of this work have directly influenced important global decisions on malaria policies, including the adoption of new antimalarial drugs. In this case study, we report on the influence of the LSTM on malaria control over the last 15 years by preparing rigorous, up-to-date, timely systematic reviews on malaria. This work has also contributed to substantive improvements in the methodological rigor and transparency of the WHO malaria policy group in evidence-based policy formulation and guideline development.
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).