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Editorial |

Registration of Clinical Trials

Frederick P. Rivara, MD, MPH
Arch Pediatr Adolesc Med. 2005;159(7):685. doi:10.1001/archpedi.159.7.685.
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The International Committee of Medical Journal Editors (ICMJE) has recently issued a statement requiring that clinical trials be registered in a public trials registry before enrollment of subjects.1 This editorial group has declared that submitted manuscripts describing a trial will be rejected if the trial has not been registered prior to the enrollment of subjects. Clinical trials are defined by the ICMJE as

The ICMJE has taken this position because currently there is no requirement that trial results be made public. Pharmaceutical companies, medical device manufacturers, and the developers of clinical procedures or patient interventions may sometimes be tempted to submit for publication clinical trials that report results favorable to products or inventions but conceal trials that report no benefit or adverse effects.2 To the extent that favorable trials are more often submitted, the published medical literature may present a distorted picture of available evidence about treatment. The ICMJE hopes that a trial registry will allow editors, journal reviewers, journal readers, and investigators who systematically review evidence to find out whether all available trial evidence for a particular intervention has been published.

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