New strategy for translational research creates new arrangements for clinical trials

The Medical Research Council (MRC) and the National Institute for Health Research (NIHR) have announced a new joint arrangement for clinical trials. The initiative forms a key part of the developing MRC- NIHR joint strategy for translational research.

As part of the strategy, a new clinical research programme called the Efficacy and Mechanism Evaluation (EME) Programme will be launched on 1 April 2008. The EME will be funded by the MRC, and administered by the NIHR as the lead organisation. The programme aims to support excellent clinical science with an ultimate view to improving health or patient care. Its remit includes clinical trials and evaluative studies which add significantly to our understanding of biological or behavioural mechanisms and processes, explore new scientific or clinical principles, evaluate clinical efficacy of interventions where proof of concept in humans has already been achieved and the development or testing of new methodologies.

The new strategy will see the EME programme working with the already established NIHR Health Technology Assessment (HTA) programme, to ensure that promising technologies are carried from the efficacy and safety stage through to being assessed for clinical and cost-effectiveness to the NHS. The HTA programme will continue to produce research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS.

The EME Programme will mainly work in responsive mode, taking applications from the research community and assessing them at regular intervals, although it may also fund proactively in particular areas of importance. Details of how to apply for funding will be available from January 2008.

Sir Leszek Borysiewicz, Chief Executive of the MRC said the new arrangements would help maintain the UK’s place in leading how research is funded and carried out:

“More than sixty years ago the MRC developed a design for clinical trials that is recognised today as the gold standard – the randomised controlled trial. The MRC is delighted to be working with NIHR to provide new opportunities for late phase clinical trials. The partnership will enable us to take promising research and turn it into effective therapies more quickly and more efficiently. We will continue to play a major role in defining direction and strategy in clinical trials.”

“This is an exciting collaboration between the MRC and NIHR in managing clinical research in the UK, and in bridging the gaps in translation of research into clinical benefit identified in the Cooksey Review,” says Professor Sally Davies, Director General of Research and Development at the Department of Health, on behalf of the NIHR. “It allows new and existing research programmes to work more closely together to ensure that the excellent biomedical research conducted in the UK is translated into excellent clinical research and real benefits for patients. Recent developments in the infrastructure for clinical research in the UK will facilitate rapid recruitment to trials.”

Details of other components of the MRC-NIHR joint strategy for health research covering discovery and exploratory development, methodology and human capital will be announced separately.

The MRC and NIHR joint arrangement has been developed with the Office for Strategic Coordination of Health Research.