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Development of novel adaptive designs to improve efficiency in clinical trials

Summary of the impact

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.

Submitting Institution

University of Reading

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Pharmacology and Pharmaceutical Sciences

Economical Experiments for the Fuel Efficiency Industry

Summary of the impact

The petrochemical industry is eager to develop advanced fuels which improve fuel efficiency both for economic and environmental reasons. Statistics plays a crucial role in this costly process. Innovative Bayesian methodology developed by Gilmour was applied at Shell Global Solutions to data from fuel experiments to solve a recurring statistical problem. The usefulness of this approach to the wider petrochemical industry has been recognized by the industry-based Coordinating European Council (CEC) for the Development of Performance Tests for Fuels, Lubricants and other Fluids, who in their statistics manual have included Gilmour's method as an alternative to procedures in the ISO 5725 standard.

Submitting Institution

Queen Mary, University of London

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Economic

Research Subject Area(s)

Mathematical Sciences: Statistics
Economics: Applied Economics, Econometrics

Impact of research into selection bias and ethical issues on published medical guidelines and legal judgements

Summary of the impact

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.

Submitting Institution

University of Warwick

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics

Improving Barclays Bank's management of its exposure to Counterparty Credit Risk

Summary of the impact

In response to the deficiencies in bank risk management revealed following the 2008 financial crisis, one of the mandated requirements under the Basel III regulatory framework is for banks to backtest the internal models they use to price their assets and to calculate how much capital they require should a counterparty default. Qiwei Yao worked with the Quantitative Analyst — Exposure team at Barclays Bank, which is responsible for constructing the Barclays Counterpart Credit Risk (CCR) backtesting methodology. They made use of several statistical methods from Yao's research to construct the newly developed backtesting methodology which is now in operation at Barclays Bank. This puts the CCR assessment and management at Barclays in line with the Basel III regulatory capital framework.

Submitting Institution

London School of Economics & Political Science

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Economic

Research Subject Area(s)

Mathematical Sciences: Statistics
Economics: Applied Economics, Econometrics

Study A leads to changes in Tuberculosis treatment guidelines

Summary of the impact

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

Submitting Institution

University College London

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Public Health and Health Services

Informing clinical policy on epilepsy treatment

Summary of the impact

A team at the University of Liverpool has undertaken research that has informed practice and policy worldwide in the management of patients presenting with newly diagnosed epilepsy, which has achieved international impact on health. Seizures are common and 3-5% of the population will be given a diagnosis of epilepsy during their lifetime. Decisions about when to start treatment, and if so with which drug are crucial and can have a significant effect on outcomes for the individual and have significant economic consequences for society. The research includes the undertaking and analysis of data from randomised controlled trials. The data analysis is based on the statistical research initiated by Dr Paula Williamson while in the Department of Mathematical Sciences at the University of Liverpool between 1996 and 2000. The research identified the most appropriate first line treatments for patients with newly diagnosed epilepsy, addressing both clinical and cost effectiveness. This work has underpinned national policy and triggered the most recent update of the NICE (National Institute for Clinical Excellence) epilepsy guidelines in 2012.

Submitting Institution

University of Liverpool

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Neurosciences, Public Health and Health Services

Quantification of the benefits of statins in preventing cardiovascular disease

Summary of the impact

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.

Submitting Institution

University of Glasgow

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Public Health and Health Services

The Feature Selective Validation (FSV) method

Summary of the impact

This case study concerns the development and subsequent uptake of the Feature Selective Validation (FSV) method for data comparisons. The method has been adopted as the core of IEEE Standard 1597.1: a `first of its kind' standard on validation of computational electromagnetics and is seeing increasingly wide adoption in industry practice where comparison of data is needed, indicating the reach and significance of this work. The technique was developed by, and under the guidance of, Dr Alistair Duffy, who has remained the world-leading researcher in the field. The first paper on the subject was published in 1997 with key papers being published in 2006.

Submitting Institution

De Montfort University

Unit of Assessment

General Engineering

Summary Impact Type

Technological

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Neurosciences
Economics: Applied Economics

Changes to European Society of Cataract and Refractive Surgery guidelines reduces loss of sight for patients undergoing cataract surgery

Summary of the impact

Research at Strathclyde has brought about a change in eye surgery practice throughout Europe and worldwide. A four-year cross-Europe study in collaboration with the European Society of Cataract and Refractive Surgery (ESCRS) investigated antibiotic treatment to prevent endophthalmitis, a complication arising during cataract operations which typically results in loss of sight. The findings showed that when the treatment is given at the start of surgery it leads to a 5-fold reduction in the risk of endophthalmitis. The European Society of Cataract and Refractive Surgery has endorsed the discovery and widely promoted the uptake of the treatment through publications and guidelines, which over the last 6 years has led to the prevention of loss of sight in thousands of patients. In Europe alone it is estimated that each year there have been 7500 fewer cases of blindness following cataract surgery as a result of the ESCRS guidelines.

Submitting Institution

University of Strathclyde

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Ophthalmology and Optometry, Public Health and Health Services

Improved Drug Development Using Supersaturated Experiments

Summary of the impact

Collaboration between the University of Southampton and scientists at GlaxoSmithKline (GSK) has resulted in the adoption of new statistical design of experiments and modelling methods for the confirmation of a robust operating region for the industrial production of new drugs. These methods have enabled larger numbers of factors to be investigated simultaneously than previously possible, improving scientific understanding of the chemical processes and producing savings of time, money and effort. Southampton's new methods were used in a key process required for the registration of a new skin cancer drug with the US Food and Drug Administration, where the research enabled the verification of a robust operating region to be completed in a third of the previous time.

Submitting Institution

University of Southampton

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Technological

Research Subject Area(s)

Mathematical Sciences: Statistics

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