Intended for healthcare professionals


Health Research Authority’s great leap forward on UK trial registration

BMJ 2013; 347 doi: (Published 25 September 2013) Cite this as: BMJ 2013;347:f5776
  1. Iain Chalmers, coordinator
  1. 1James Lind Initiative, Oxford OX2 7LG, UK
  1. ichalmers{at}

Trial registration is now required as a condition of ethical approval. The recently published report of the House of Commons Science and Technology Committee is the latest of numerous calls for the registration of clinical trials.1 Nearly three decades ago, oncologist John Simes showed how prospective trial registration could help to detect and take account of biased under-reporting of clinical trials.2 Other academics then showed how under-reporting of clinical research can harm patients,3 characterising it as a form of scientific misconduct.4

In the mid-1990s, the publisher Current Controlled Trials offered trial registration in its international randomised controlled trial register (ISRCTN; Some research funders in the United Kingdom, such as the Medical Research Council, Wellcome Trust, and NHS Research and Development Programme, required the trials that they were supporting to be registered. In the United States, the FDA (Modernization) Act 1997 required registration of clinical trials of treatments for serious or life threatening diseases, and a US national register ( was established as a result. In some other countries, Spain for example, registration of all clinical trials became required by law.

Despite these developments, trial registration remained patchy. It was not …

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