Clinical trials are bureaucratic, opaque, and offputting to researchers and patients, MPs hearBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1711 (Published 14 March 2013) Cite this as: BMJ 2013;346:f1711
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There is no doubt that MPs should be appraised of the problems which beleaguer the running of clinical trials in the UK. Anyone who has had a hand in the approval and running of a clinical trial will be aware of a trial’s magnetic attraction for bureaucracy.
Professor Rawlins’ evidence, however, should be corrected on a single but crucial point regarding what he claims to be one of the ‘two main barriers’ namely the ‘plethora of ethical approvals’ needed for a clinical trial. This is simply wrong; only a single favourable opinion is required from one of the National Research Ethics Service (NRES) Research Ethics Committees in order to undertake a clinical trial in the UK. Whilst there are important barriers to be overcome it should also be acknowledged that NRES has worked, and is working hard, to improve the situation. Long gone are the days of multiple approvals from multiple RECs all having their own application forms and individual operating procedures. RECs now provide a professional and efficient service accessible via the Integrated Research Applications System (IRAS). I would suggest that what Professor Rawlins really has in mind are the Research and Development procedures which remain cumbersome and fragmented. NRES deserves praise for the responsive and on-going programme of reform it has put in place and developed that ensures that the UK has a system of ethical review of clinical trials that is the envy of many of our European colleagues.
Competing interests: No competing interests