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Post published on Twitter/X on 27 Sep 2013 03:02

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I. Chalmers (2013). Health Research Authority's great leap forward on UK trial registration. BMJ, 347(sep25 2), f5776-f5776. BMJ.

Publication date
25 Sep 2013
Identifier
10.1136/bmj.f5776
Authors
I. Chalmers
Source
BMJ
Details
347(sep25 2), f5776-f5776
Reference type
article
Publisher
BMJ
Metadata source
crossref

Abstract

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; www.controlled-trials.com). 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 (www.clinicaltrials.gov) 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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