The International Committee of Medical Journal Editors (ICJME) has established a requirement that all randomized clinical trials (RCT) be entered into a public registry before the onset of patient enrollment as a condition of consideration for publication. The definition of a clinical trial established by the ICMJE is any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.
All Brieflands journals require randomized clinical trial registration in public trial registries such as the National Institutes of Health and the International Standard Randomized Controlled Trials.
The RCT code will be included in the identifier number in Clinical Trial articles. This rule is concluded from ICMJE website for their editorial and updates on the topic of registering clinical trials before the publication of the results. The ICMJE recommends that the clinical trial registration number be included at the end of the abstract. A sample of general display format for the code obtained from ClinicalTrials.gov is: an alphabetic label of ClinicalTrials.gov followed by a slash and then an 11-digit alphanumeric string starting with NCT followed by eight numbers.
ClinicalTrials.gov or similar registries provide a vehicle that allows organizations and individuals to provide the data requested by ICMJE, which has adopted the World Health Organization (WHO) minimal registration data set. Brieflands Journals accept registration in the following registries:
The Phase III trials must be registered, and phase II trials are appropriate to register. Most phase I trials do not need to be registered. Please clearly state in the Methods section of the manuscript the trial registration number including where the registration is publicly available. Visit the website of the Consolidated Standards of Reporting Trials (CONSORT) for more information.
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