Introduction

We have expertise in developing and assessing the novel methodology that underpins innovative clinical trials. Our interests include medical and clinical trial ethics, use of qualitative and mixed methods, quantitative methods including clinical trial statistics and development of patient reported outcome measures (PROMs). Our methodological work informs guidelines and we work closely with our colleagues in Warwick Clinical Trials Unit and other institutions to bring novel methodology to practical application. 

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Clinical Trials Unit

The Warwick Clinical Trials Unit (WCTU) has a strong track record in delivering excellent research. Established in 2005, we received full registration status from the UKCRC in 2007.

Warwick Primary Care

Warwick Primary Care is engaged in clinical trials. For example, Socwell is a randomised controlled trial which evaluates an internet self-help package for sub-clinical social anxiety and its effect on quality-of-life, mental well-being, depression and general anxiety.

Mental Health & Wellbeing

Our Mental Health and Wellbeing academics are involved in clinical trials through the CIRCLE study, which is a randomised controlled trial of the clinical and cost-effectiveness of a psychological intervention incorporating adjunctive contingency management for reduction of cannabis use and of relapse in early psychosis.

Warwick Medicine, Ethics and Society

We have a research interest in the ethics of recruitment and consent processes for trials involving participants from vulnerable populations including trials in emergency care and in people with cognitive impairment. Trials that we have recently been involved with include DAPA and PARAMEDIC2.

Understanding how an intervention works, why it does not work and how it is experienced requires a mixed methods design combining data from observation and interviews with data captured as part of the trial and publicly available data. One example is the Chronic Headache Education and Self-management Study (CHESS) to investigate whether a new education and self-management programme will help improve quality of life for people living with chronic headaches.

Statistics and Epidemiology

The Statistics and Epidemiology group develop and apply innovative statistical methods for clinical trials with major research programmes in adaptive trial designs and analysis, clinical trials in small population groups and collaborate closely with Warwick Clinical Trials Unit. One of the trials we are involved with that incorporates the adaptive design is START:REACTS.

Centre for Health Economics at Warwick (CHEW)

CHEW is working on new methods in a range of areas. These include: cost-effectiveness conditional power computations for stopping clinical trials early (as part of the START:REACTS trial); methods and strategies for trial-based economic evaluation of complex interventions in resource constrained settings (STREAM and MILESTONE trials) and within multi-arm multi-stage trials; and developing multivariate linear and generalised linear mixed-effects models for analysis of trial-based cost-effectiveness data.

Warwick Research In Nursing

We bring significant expertise and experience in patient-reported outcomes (PRO) research of relevance to clinical trials including: Core Outcome Set development, and PRO measure (PROM) development, psychometric and qualitative evaluation, reviewing and selection for clinical trials. One of the trials we are involved with include CHESS (psychometric evaluations) and Core Outcome Sets for Headache (COSH), a sub-study of CHESS. Other works include Core Outcome Set for Cardiac Arrest (COSCA) initiative which is a partnership between patients, their partners, clinicians, research scientists, and the International Liaison Committee on Resuscitation.

Centre for Health Economics at Warwick (CHEW)

CHEW is working on new methods in a range of areas. These include: cost-effectiveness conditional power computations for stopping clinical trials early (as part of the START:REACTS trial); methods and strategies for trial-based economic evaluation of complex interventions in resource constrained settings (STREAM and MILESTONE trials) and within multi-arm multi-stage trials (ROSSINI 2); and developing multivariate linear and generalised linear mixed-effects models for analysis of trial-based cost-effectiveness data.

Centre for Health Economics at Warwick (CHEW)

A core body of our work involves economic evaluations conducted alongside randomised controlled trials coordinated by the Warwick Clinical Trials Unit. Our research involves work on economic aspects of health and disease, economic evaluations of aspects of care, and the design and evaluation of health systems.