This is the author’s final draft of the paper published as Lancet Oncology, 2008, 9 (8), pp. 700-701. The final published version is available at http://www.sciencedirect.com/science/journal/14702045. DOI: 10.1016/S1470-2045(08)70184-0The European Clinical Trials Directive 2001/20/EC aimed to harmonise standards for clinical trials throughout the European Union, and was implemented in UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004. As a result, all trials of investigational medicinal products must comply with the Guidelines for Good Clinical Practice issued by the European Medicines Agency, and undertaking a trial now requires a range of approvals from different agencies. These approvals are generally sought in parallel. Clinical trial authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA; London, UK) is required, but before applying to the MHRA, the approval of the trial sponsor must be obtained, and the trial must be registered with the European Clinical Trials Database. Research governance approval from the UK National Health Service (NHS) organisations in which the trial is to be done must be given. An important requirement is a favourable opinion from a Research Ethics Committee (REC). A REC application involves completion of a form and submission of supporting documentation, which is then considered at a REC meeting to which applicants will be invited to attend. Details of success rates of applications to RECs specifically to undertake cancer trials are unknown, but numbers from the National Research Ethics Service (NRES), which coordinates the REC system, suggest that only 17% of all applications receive a favourable opinion at first review by a REC in the UK.1 Most (66%) of opinions are provisional and require further response and modification before a final decision is rendered, whereas 8% of all submissions receive an unfavourable opinion (the remainder are withdrawn or otherwise deferred)
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