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 …

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