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International Committee of Medical Journal Editors' Definition of a Clinical Trial
- Christine Laine, MD, MPH, Senior Deputy Editor
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
IN RESPONSE:
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.
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
Article and Author Information
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Potential Financial Conflicts of Interest: None disclosed.
