CTSU resubmission: Proposal to increase capacity for methodological improvements in clinical trials

Lead Research Organisation: Medical Research Council

Abstract

Oxford University?s Clinical Trial Service Unit already provides methodological advice across the different phases of major clinical trials (design, conduct, analysis and interpretation) to a large number of research groups in Oxford, elsewhere in the UK and internationally. It aims to improve the quality of these trials (e.g. more patients recruited more rapidly; better data quality and study conduct) in order that they generate more reliable evidence about the effects of treatments on mortality and major morbidity. MRC hub funding would be used by the CTSU to increase its leadership role in two main areas. Firstly, providing guidance to clinical experts on the design and conduct of trials (chiefly in vascular and neoplastic diseases); and, secondly, developing efficient and secure IT systems to facilitate the conduct of large-scale trials. More reliable evidence from better trials should lead to substantial improvements in public health.

Technical Summary

The CTSU has had productive collaborations over a long period with clinical trial units and researchers locally, nationally and internationally. There are increasing demands on us for help with the methodological support of clinical trials, and our previous use of core funding to support these activities has been very cost-effective. The MRC?s plan to establish clinical trial hubs recognises the need for this type of work. But, the extent to which the CTSU is currently able to provide such support for trials is severely limited by the available resources. MRC hub funding would allow the CTSU to extend its innovative methodological work on trials. In particular, this funding would be used to support the time of senior scientific staff to help external researchers develop trials that address key clinical questions reliably, and senior IT staff to help develop innovative methods for conducting trials more efficiently and effectively. It would also allow the CTSU to develop further our local and national collaborations with other clinical trials units and to help with streamlining clinical trial regulatory procedures, as well as to increase our capacity for training. MRC hub support would be accessible to external researchers via the CTSU web-site and/or via direct contact with members of the CTSU staff.

In December 2007, the CTSU had a quinquennial review by the MRC, and the review panel gave us the maximum overall rating of 6 out of 6 (?exceptional and at the leading edge internationally?), with a similarly high rating for the unit?s previous methodological support of clinical trials (including the IT and laboratory developments). The review panel recommended an increase in the CTSU?s core funding (which has now been endorsed by the MRC?s Health Services and Public Health Board) and suggested that additional support for our methodological work on trials should be obtained from the present MRC funding call. So, in order that the CTSU can extend its innovative methodological research related to clinical trials, as well as increase the level of support on trial methodology to external clinical researchers and other trials units, we are seeking support of additional posts for these areas of work. As in the past, the value of CTSU?s methodological work on clinical trials should be assessed in terms of the numbers of trials given such support that successfully answer important clinical questions, as well as our impact on improving systems for the recruitment and conduct of trials.

Publications

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Haynes R (2014) Effects of lowering LDL cholesterol on progression of kidney disease. in Journal of the American Society of Nephrology : JASN

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Haynes R (2014) Evaluating the contribution of the cause of kidney disease to prognosis in CKD: results from the Study of Heart and Renal Protection (SHARP). in American journal of kidney diseases : the official journal of the National Kidney Foundation