Clinical trials across the UK are being redesigned from the ground up by a collaboration of four universities—Liverpool, Lancaster, Bangor, and Manchester—that tests and improves the methods used to run them. The problem is that even well-funded trials can produce unreliable results if they are poorly designed, use the wrong measurements, or fail to reflect what matters to patients. This hub exists to fix that. It brings together statisticians, health economists, sociologists, and psychologists to study the machinery of trials themselves: how to pick the right drug dose in early safety tests, how to measure whether a treatment actually works in routine care, and how to incorporate patient experience into trial design. If the hub succeeds, future clinical trials will be faster, cheaper, and more trustworthy. That means doctors and regulators can make better decisions about which drugs to approve and which treatments to prescribe. The work also feeds directly into everyday medical practice—for example, through the COMET initiative, which develops standardised outcome measures so that different trials can be compared, and through training programmes that produce the next generation of trial experts. The hub has a particular focus on drug safety, children’s medicines, mental health, epilepsy, cancer, and surgical trials.
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The Medical Research Council funded North West Hub for Trials Methodology Research (NWHTMR) is a collaboration which brings together experts in clinical trials research from the Universities of Liverpool, Lancaster, Bangor and Manchester. Clinical trials are studies conducted in patients to evaluate the potential benefits (and risks) that new treatments could offer. They provide the 'gold standard' evidence base for informing and improving future patient care. The Hub has experts in medical statistics, clinical trials methods, pharmacoeconomics (drugs are compared for their value), sociology and clinical psychology. The Mission of the Hub is to create a world-class centre where methods used in clinical trials can be investigated. The overall aim is to improve patient care by making sure we test, use and develop the best methods possible for clinical trials. This will help to make sure that research studies are relevant and correctly measuring what we want to measure. The Hub also works in collaboration with patients and service users to make sure their experiences of clinical trials and health conditions are included in developing better methods for carrying out clinical trials. Together we are committed to making sure that the best methods possible to design, run and analyse clinical trials are researched, developed, used and further evaluated. The Hub focuses on four themes: - Early phase trial design and analysis, (when drugs are first researched to check for their safety and to see what effect they have) - Later phase trial design and analysis and (when drugs are checked to see how well they work in routine care) - Patients' perspectives, (what patients' experiences of taking part in clinical trials are) - Efficacy and mechanism evaluation of targeted therapies (choosing the right drug or drug dose to give to a patient, sometimes referred to as 'personalised medicine') We want to make sure that we develop good methods that can be used in key clinical areas and we have a particular interest in drug safety, medicines for children, mental health, epilepsy, cancer, surgical trials and infection. The major aims of the Hub are to: - Provide a world-class environment for carrying out research that will improve the design, conduct and analysis of clinical trials; - Make sure that our findings are used to improve the methods used in future clinical trials. - Set up training programmes to develop the next generation of clinical trial experts. - Work in partnership with others, both in the public sector and industry. The key objectives are to: - Improve the design, conduct, analysis and reporting of clinical trials; - Develop a methodological research portfolio generated by a broad team of investigators from a range of disciplines; - Build on considerable local Cochrane expertise to improve the integration between trials and systematic reviews in relation to trial design and reporting; - Use local strengths in pharmacology (the study of drugs) to improve the design of drug clinical trials; - Train the next generation of clinical trials experts; - Work well with industry in developing good clinical trials; - Publicise the work that we have done. Key achievements to date include: - The COMET (Core Outcome Measures in Effectiveness Trials) Initiative (www.comet-initiative.org) - this project works with international experts and patients interested in the development and application of agreed standardised sets of outcomes, known as 'core outcome sets'. - The Database of Instruments for Resource Use Measurement (DIRUM www.dirum.org), (A bank of tested questionnaires for use by health economists) - A network meeting "Improving accrual and recruitment conduct in clinical trials with children and other patients unable to consent for themselves" (http://www.liv.ac.uk/nwhtmr/events/past_events/recruit_meeting.htm. Further details are available at http://www.liv.ac.uk/nwhtmr.
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