Improving clinical research

In the post-genome era, clinical research couldn't be simpler. Exposure to human disease stimulates an enquiring mind to investigate underlying pathogenesis or new therapeutic targets. New functions are ascribed to genes that shed new light on cellular biology. Exciting stuff, but I am a clinician first and desperate to return this new found knowledge to patients to improve their outcome. It is here that the system fails us, resulting in a detrimental impact on the NHS and care for patients. The Academy of Medical Sciences has identified several factors that impair translational research¹—defined as experimental medicine and clinical trials. Lack of research funding for clinical trials, inadequate facilities to undertake patient orientated clinical research, limited numbers of clinical academics, the threat of increasingly complex legal and ethical governance issues, and failings in the NHS are highlighted as contributory factors. Eleven recommendations are made.

Modelled on the clinical research centres in the United States, the Wellcome Trust has funded five purpose built clinical research facilities for patient orientated clinical research across the United Kingdom. The new clinician scientist scheme has helped develop the careers of aspiring researchers, and despite cutbacks, most funding bodies in the United Kingdom have ringfenced resources to protect clinical research fellowships.² However, there are only 50 clinician scientists across the United Kingdom, and expansion of training programmes for clinical academics committed to clinical research is needed. Clinical trials are resourced—but the MRC funded just eight trials in 2001-2, of which only four were new.³ So there are pockets of activity, but these amount to a drop in the ocean.

So how could we make a major impact relatively quickly? Although council and charity research funding in the United Kingdom seems unlikely to increase in the short term, a greater emphasis could be placed on funding clinical compared to basic "medical" research. The most immediate impact however could come from a major scrutiny and overhaul of existing funding from the NHS research and development programme, which was established in 1994 to provide 1.5% of total NHS expenditure to support clinical research.⁴ This target has never been met, but the Department of Health currently provides £534m/year—over £100m more than the annual expenditure of the MRC and Wellcome Trust. Some of this funding has been put to good cause, notably providing direct costs to the National Translational Cancer Research Network, which informs the NHS on advances in cancer treatment.⁵ The majority of the budget is disseminated to local NHS trusts, supposedly to pay for a share of staff and facilities to underpin research funded by councils and charities. Despite pleas to the contrary⁶ it is easy to be critical of this model. The system is iniquitous, with huge geographical variations in allocating funds that bear little relation to research output. It lacks a robust peer review process and often suffers from an inability to identify, direct, and change allocation of resources at the level of the NHS trust.

The reality is that this income currently underpins routine clinical care far more than it does research and therefore fails in its remit. Proof of this came from the recent experience with the Wellcome Trust clinical research facilities, where capital costs were met by Wellcome but running costs were dependent upon income from NHS research and development. Four years later the successful NHS trusts have received additional support from the NHS programme because of an inability to recoup existing funds, which were embedded in clinical care.

The academy believes that for an investment of £25m in each case, the United Kingdom could reproduce the success of the National Translational Cancer Research Network programme in other areas.¹ Value for money would be ensured by such national consortia creating a virtual "national institute for health." Based on the experience of the National Translational Cancer Research Network such platforms would also attract support from pharmaceutical companies.

The report from the academy concludes with a plea to articulate the benefits of clinical research back to patients, and so we must. In the interim we might start by publicising the inefficiencies embedded in research and development in the NHS and a more transparent allocation of this income to clinical research rather than clinical care. Implicit in this reorganisation is a desperate need to educate government. Current criteria for the performance of NHS trusts are driven by clinical variables with no mention of research. Consultants, faced with increasing demands to meet clinical targets (arguably perpetuated in the new NHS consultant contract), are progressively becoming deskilled in research. If this system does not change research driven teaching hospitals will be a distant memory. Governments increasingly seek rapid returns from research often within a term of office, yet this is not reality. For example, recent trials establishing aromatase inhibitors as a superior treatment to tamoxifen for women with breast cancer⁷ will undoubtedly save lives, but it was over 20 years ago that Miller et al first reported the enhanced expression of aromatase in breast tumours.⁸

If acted upon, the recommendations from the Academy of Medical Sciences might ensure that the NHS does not become solely a point of service delivery. A failure to underpin clinical research now will result in a cost to human life, maybe not today or tomorrow, but certainly over the next 10-20 years. We need to lobby for more council funding, work on academic career structures, and combat restrictive legislature that may impede clinical research along the way. A critical appraisal of research and development in the NHS perhaps seems the most fruitful avenue for immediate progress. The NHS must revitalise a research ethos in its organisation to ensure that it can deliver optimal care for patients for years to come.