Midland Hub for Trials Methodology Research at University of Birmingham

Clinical trials test potential treatments in humans to see if they should be approved for wider use in the general population. Any new treatment must be extensively tested to check that it benefits patients, is safe and doesn t have unacceptable side effects. Most often the treatment is a drug, but it could be a medical device, a surgical or physical procedure, a therapy or an intervention such as health promotion. Volunteers are recruited into the clinical trial to undergo the new treatment and usually the trial will include a group who just receive the standard treatment. In this way, the outcome of patients on the new treatment can be compared to the standard to see if it is beneficial. Planning how the trial will be run and making sure it addresses the right questions are important to ensure that the results from the trial will be useful. Interpreting the data that is collected in the trial also needs to guarantee that valid conclusions are reached. The plan for this research is to create a regional facility at the University of Birmingham in which to investigate the best ways to design, conduct and analyse trials, providing advice, support and training to those carrying out trials and to the public. Ultimately this will result in beneficial treatments being delivered to patients more efficiently.

The aim of the Midland Hub at University of Birmingham is to be a centre of excellence for trials methodology research, providing local and national researchers undertaking trials with innovative methodology for design, conduct and analysis, thereby improving the quality of trials. The Hub will develop existing expertise in trials methodology at Birmingham to deliver a high-quality Research Programme that will be of practical use to the trials community. There is a culture of collaborative working at Birmingham and the Hub will continue to cultivate regional, national and international collaborations to facilitate the successful delivery of research. A comprehensive training programme in trials methodology will train the potential experts of the future and educate trial practitioners in methodology. By providing a mechanism for advice, support and dissemination the Hub will benefit the trials community and ultimately patient care.
Our proposed research programme centres around the current specialist methodological areas but the wealth of expertise will enable us to develop new research themes identified as important by the clinical trials community. There are seven key research themes at Birmingham: (1) Quality of life evaluation for clinical and health economic assessment; (2) Discovery and evaluation of diagnostic, prognostic and predictive biomarkers; (3) Methods to obtain reliable conclusions and involve users; (4) Bayesian methods in design and analysis of trials; (5) E-trials; (6) Systematic review for clinical and health economic assessment; (7) Education in trial methodology. Methodological expertise within the Research Programme feeds into all major areas within the trial process i.e. pre-trial development, trial design and set-up, trial conduct, trial analysis and evidence synthesis.
In summary, Birmingham is at the heart of the trials community, providing academic expertise based on real-life trial experience, ready access to a wealth of datasets that can be used for methodology research, real situations in which to implement new methodology and direct support to many members of the clinical trial community. As one of the leading centres in the UK for clinical trials, the University of Birmingham is the ideal location for the Midland Hub for Trials Methodology Research.