North West HTMR

The best method for finding out whether one treatment is better than another is to perform a research study known as a randomised controlled trial, in which treatments are allocated to patients at random, rather like throwing a dice to decide. Studies like this are not without their difficulties. For example, when drugs are first trialled, the research should proceed in stages with evaluation at each stage. As treatments move into the later phases of study, researchers must choose which outcomes are most important to measure, a decision ideally arrived at through consideration of both the clinical and patient perspective. This proposal is to create a world-class centre where issues such as these facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the evidence on which decisions about healthcare are based.

The gold standard study design for determining efficacy of a treatment is the randomised controlled trial (RCT) but trials are not without their difficulties (Prescott et al, 1999). This proposal is to create a world-class centre where methodological issues facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the validity and relevance of the healthcare evidence base. This will include provision of a training programme that will deliver individuals with the capacity to be leading clinical trialists and methodologists.

The Hub will focus on selected methodological research themes, initially developing and translating the methods for application across four clinical areas. The methodological areas include the promotion, modification and implementation of recently devised methods for improving the efficiency of a wide variety of early phase trials, the enhancement of the link between the findings of systematic reviews and the design of later phase trials particularly in relation to outcome selection (Clarke 2007, Sinha 2008), the development and application of methods of adjustment for non-compliance in both clinical and cost effectiveness analyses, and ensuring that the design and conduct of trials over their entire lifecourse is informed by evidence on the perspectives of patients. This will enable the design, interpretation, and dissemination of the results of RCTs that are of greater relevance to stakeholders.