The University of Birmingham hosts the MRC Midland Hub for Trials Methodology Research (MHTMR), one of the seven research facilities in the MRC Network of Hubs. This facility is dedicated to providing research, training and advice on methodology to trial practitioners. Key areas of research expertise and research activity include (i) quality of life evaluation for clinical and health economic assessment (ii) discovery and evaluation of diagnostic, prognostic and predictive biomarkers (iii) phase II clinical trials (iv) evaluation of non-drug interventions, particularly radiotherapy (v) trials in rare diseases (vi) time-to-event analysis (vii) issues in trial conduct (viii) Bayesian methods (ix) systematic reviews and decision modelling for clinical and health economic evaluation.
The Clinical Trials Units at Birmingham have a key advantage in their co-location with the Health Economics Unit which is a leading research facility in health economics in the UK. Researchers from the Health Economics Unit are collaborators on many of the clinical trials run by the Trials Units, providing expertise on health economic evaluation of the interventions being assessed within trials.
The Research Design Service for the West Midlands (RDS WM) funded by the National Institute for Health Research has three hubs located at the Universities of Birmingham, Keele and Warwick. The RDS provides support to workers in the West Midlands who need help in working up a research proposal, including clinical trials, for submission to peer-reviewed funding programmes in applied health and social care. The RDS collaborate with the MHTMR in methodological aspects of trial design.
The Birmingham Clinical Research Academy represents a collaboration between the University of Birmingham and the University Hospitals Birmingham NHS Foundation Trust. It is a ‘one-stop-shop’ to facilitate applied and translational health research collaborative grant applications. It provides support across the process, from identifying the funding stream, refining the research idea to costing and setting up contracts.
Each Clinical Trials Unit within BCCT has a comprehensive Quality Management System in place and the Research Support Group has a wealth of experience regarding Research Governance surrounding clinical trials. The BCCT is committed to running trials to high quality standards. For this purpose it is in the process of setting up its own portfolio of Standard Operating Procedures (SOPs) covering all aspects of clinical trials, from trial management to laboratory management via the Clinical Research Compliance Team. It will also provide audit and QC support. Any relevant processes can be found on the R&KT Office webpage.
The BCCT maintains oversight of its trial portfolio via the Clinical Trials Oversight Committee - see their Terms of Reference for details.