Intended for healthcare professionals


Senior UK researchers campaign for sensible guidelines on regulating trials

BMJ 2009; 339 doi: (Published 08 September 2009) Cite this as: BMJ 2009;339:b3671
  1. Trish Groves, deputy editor
  1. 1BMJ

    The over-regulation and bureaucracy stifling the initiation and conduct of clinical trials have been well publicised, said senior clinical triallists attending a meeting in Oxford this week. What’s needed now, they said, are workable solutions.

    The two codirectors of the University of Oxford’s clinical trial service unit summed up the frustration expressed by most speakers and delegates. “We don’t just need to simplify the individual rules. How many of them are needed at all?” Richard Peto asked, while Rory Collins added: “How much longer do we have to do things that don’t add value?”

    An invited international audience of clinical researchers, industry leaders, regulators, funders, ethicists, and patients’ representatives debated the many barriers to the efficient running of trials, particularly multicentre international trials run by academics.

    Although such trials often pose little clinical risk to patients or legal or insurance risk to institutions and sponsors, they have to go through the same hoops as potentially high risk trials of new drugs and devices. Regulation, monitoring, and inspection of trials could be minimised, speakers said—for instance, by moving towards remote monitoring using statistical analyses instead of numerous site visits—while still ensuring that scientific objectives are met and that participants’ safety and privacy are protected. But trial auditors are not currently trained to stratify their assessments by risk.

    Many of the speakers confirmed that the problems they had highlighted two years ago at a similar meeting held in Washington, DC, by triallists from McMaster, Duke, and Oxford Universities were still unresolved.

    There was, however, some good news. Sally Davies, director general of research and development for the Department of Health and NHS in England, and Janet Darbyshire, head of the Medical Research Council’s trials unit, explained how the United Kingdom has recently harmonised and streamlined procedures for initiating, registering, governing, and conducting nationally funded trials within the NHS.

    These processes are largely coordinated through the National Institute of Heath Research and its comprehensive research network. Researchers can now use the institute’s integrated research application system to complete most procedures and provide trial related information only once for multiple uses. Studies no longer need approval by both national and a series of local ethics committees, and the single portal may also greatly simplify seeking permission from NHS trusts to recruit patients to a trial.

    Delegates said that all this has made life much easier for UK based researchers and offers patients greater opportunities to take part in and benefit from research, and it may also make the UK a more competitive and attractive setting for international trials.

    Ingrid Klingmann, project coordinator of the European Forum for Good Clinical Practice, reported on progress towards simpler regulation and monitoring of trials in the European Union. However, she said that although the EU Clinical Trials Directive was intended to make research easier, overcomplicated implementation of the directive has delayed trials and greatly increased their costs, as shown in evidence from last year’s international, multidisciplinary survey on the impact on clinical research of European legislation and critical reports from the European Science Foundation and European medical research councils.

    Although Dr Klingmann acknowledged that it’s not yet clear whether the European Commission will insist on just a single application for each multicentre trial, some aspects of monitoring and inspecting of trials and the reporting of adverse events are already being streamlined.

    Judith Kramer, of Duke University, Durham, North Carolina, explained how the university’s clinical trials transformation initiative (CTTI) is identifying and evaluating best practices in governing and conducting clinical trials. Current projects are looking at the best ways to monitor trials, to manage data collected in cancer trials, and to improve the communication of serious adverse events and the public reporting of clinical trial data. The CTTI is a joint venture with the US Food and Drug Administration, which involves collaborating with academia, industry, patients, the US National Institutes of Health, and the European Medicines Agency.

    Zhang Jingli, a deputy commissioner from China’s State Food and Drug Administration, reported that China is planning to work closely with research regulators in Japan and Korea and to harmonise their procedures. China has a new and highly devolved system of governing clinical research, with 31 provincial food and drug administrations, 339 municipal agencies, and more than 2000 county committees. It currently takes about a year to gain approval for an international trial in China, and he welcomed advice and collaboration to develop a better system.


    Cite this as: BMJ 2009;339:b3671