Intended for healthcare professionals


A risk adapted approach to the governance of clinical trials

BMJ 2011; 343 doi: (Published 25 October 2011) Cite this as: BMJ 2011;343:d6756
  1. Rosalind L Smyth, Brough professor of paediatric medicine
  1. 1Department of Women’s and Children’ Health, Institute of Translational Medicine, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Liverpool L12 2AP, UK
  1. r.l.smyth{at}

The research community needs to support a new initiative to reduce the regulatory burden

Over the past three to five years, there has been a barrage of criticism and dissent about the complex and bureaucratic systems that govern clinical research in the United Kingdom. This has culminated in sweeping recommendations, made in a report by the UK’s Academy of Medical Sciences,1 which have been endorsed by government.2 However, many of these recommendations (such as revision of the European Union Clinical Trials Directive and establishment of a health research regulatory agency) will take time and require new legislation, so initiatives to tackle these problems now are timely and welcome.

One such initiative is the implementation, since April 2011, by the Medicines and Healthcare Products Regulatory Agency (MHRA) of a risk adapted approach to the regulation of clinical trials of investigational medicinal products.3 This approach defines three types of trial according to the risks associated with the product—none (A), some (B), and markedly higher (C) than for standard medical care. A type A trial would typically investigate products used according to their licensed indications in the EU. A type B trial might be of a product, licensed in …

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