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There are a number of inaccuracies in the article by D. Hunter, which the Health Research Authority (HRA) and Medicines and Healthcare Products Regulatory Agency (MHRA) in collaboration would like to take the opportunity to clarify.
The article refers to clinical trials being ‘highly regulated’ by research ethics committees (RECs), which is not strictly accurate. Clinical trials are regulated by the competent authority (in the UK, this is the MHRA). Clinical trials may only run once they have been authorised by the MHRA and receive a favourable ethical opinion from an REC. However, the issue of recruitment is an issue for the REC to consider when deciding whether to issue the favourable opinion.
D. Hunter states in the article that non-study-specific advertisements for phase 1 clinical trials fall into a regulatory loophole as they fall outside the requirement for review by an REC, as set out in the Association of the British Pharmaceutical Industry (ABPI) code of practice. This is not entirely accurate as the HRA, …
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.