Christine Laine, MD, MPH, Senior Deputy Editor
Laine C. International Committee of Medical Journal Editors' Definition of a Clinical Trial. Ann Intern Med. 2005;143:847. doi: 10.7326/0003-4819-143-11-200512060-00024
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Published: Ann Intern Med. 2005;143(11):847.
The editors of Annals of Internal Medicine wholeheartedly agree with Dr. Campillo-Artero's statements about the supremacy of randomized, controlled trials over trials that do not use random assignment. However, because the goal of the ICMJE policy on trials registration was to promote accessibility to clinically directive experimental research, the committee adopted a broad definition of clinical trials (1). Of note, the Ottawa Group, working closely with the World Health Organization to promote comprehensive trials registration, defines trials in an even broader manner than does the ICMJE. According to the Ottawa Group (2), trial refers to “a prospective controlled or uncontrolled research study evaluating the effects of 1 or more health-related interventions assigned to human participants.” Recent trial registration efforts fully realize that randomized, controlled trials provide the most definitive evidence for causal relationships between interventions and health outcomes. However, other types of trials are sometimes the best available evidence to guide clinical practice. For this reason, the ICMJE believes that a comprehensive trial registry should contain information about any research project that prospectively assigns human participants to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.
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