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Registration of Clinical Trials
Arch Pediatr Adolesc Med. 2005;159:685.
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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
any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.1(p1364)
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 . . . [Full Text of this Article] AUTHOR INFORMATION
Frederick P. Rivara, MD, MPH
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