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MRC to fund more trials of complex treatments

London Owen Dyer

The UK Medical Research Council (MRC) plans to promote a broader range of clinical trials, moving away from a narrow focus on drug interventions to study complex treatments such as behavioural therapy.

The MRC, the UK’s largest public sponsor of randomised controlled trials, will also fund more research into mental health, according to its new report on the future of clinical trials.

The report comes after an 18 month review of the MRC’s work in promoting clinical research in Britain. Over 1000 questionnaires were sent to interested groups and organisations, 221 of which replied. Trials funded by the MRC in developing countries will be considered at a later date.

The organisation is considering ringfencing funds for the developmental stages of studies involving complex or multiple interventions, since funds for such research are often hard to come by. Studies that include qualitative as well as quantitative results are also to be encouraged.

Problems include the lack of financial incentives for NHS trusts that are considering investing in clinical research and the difficulty in securing NHS funds for the treatment costs of trial participants. Typically, when the MRC funds a clinical trial it bears the cost of gathering and analysing data, while the NHS pays for the treatments being studied. While the health department makes about £400m ($640m; €565m) a year available for this purpose, many applicants complain of bureaucratic obstacles to using the money.

The MRC is currently negotiating with the Department of Health to find ways to make research more attractive to NHS executives. It will also set up a communications initiative, headed by Professor Iain Chalmers, which "could encourage recognition of trusts that make major contributions to publicly funded studies."

Professor Chalmers told the BMJ: "There’s quite a dramatic mismatch between what’s actually being done, mainly drug studies, and what people declare that they would like. I cling to the hope that the public will get more involved in helping to set the research agenda, and that some of the distortions that currently dictate what gets studied might be leavened by input from the people for whom these studies are actually done, or at least purport to be done. Everyone else, in some sense, has a vested interest."

Professor Chalmers’ group will also be charged with encouraging communication between researchers and patients involved in clinical trials. Future applicants will be required to show a plan for informing participants of trial results, and the MRC will encourage research on the effects of consumer involvement in clinical trials.

Currently, the average wait before a funding application is granted or refused is about 12 months. The MRC hopes to speed up this process, but at the same time it will be introducing a new "feasibility" stage in the application process, which is designed primarily to weed out studies that are likely to fail because of poor recruitment and retention of participants.

The council is revising its guidelines on the role and remit of independent trial steering committees, which often, according to the report, act as advocates for the trials they are supposed to oversee. It will also expand its training programme for trial managers and may also set up a central office to help researchers deal with regulatory issues such as those raised by the EU directive on good clinical practice in trials of medicinal products.

Clinical Trials for Tomorrow is available at www.mrc.ac.uk
 
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