Clinical trial registration
General information
Adv Clin Exp Med follows the International Committee of Medical Journal Editors (ICMJE) guidelines, which require and recommend registration of clinical trials. As a condition of consideration for publication, all clinical trials must be registered in a publicly accessible trial registry at or before the time of first patient consent for enrollment.
For the purposes of this policy, a clinical trial is defined in accordance with the ICMJE as a research project that prospectively assigns individuals or groups of individuals to a health-related intervention, with or without a concurrent comparison or control group, in order to study the relationship between the intervention and a health-related outcome.
The registry should meet ICMJE requirements and provide a complete, publicly accessible registration record. Approval by an ethics committee, institutional review board, or other research ethics body does not substitute for prospective trial registration. Retrospective registration, including registration at the time of manuscript submission, does not normally satisfy this requirement.
Pure observational studies do not require registration. A clinical trial does not only refer to studies that take place in a hospital or involve pharmaceuticals but also to all studies that involve participant randomization and group classification in the context of the intervention under assessment. Secondary analyses of data from a previously registered clinical trial should not be registered as separate clinical trials. They should cite and report the parent trial's registration number.
In exceptional circumstances, the Editors may consider a manuscript reporting a trial that was not prospectively registered. Such exceptions should be rare. If an exception is made:
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the trial must be registered before publication;
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the authors must explain when registration was completed and why it was delayed;
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the publication must include a statement explaining the delayed registration; and
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the journal will disclose why an exception to the prospective-registration requirement was permitted.
The clinical trial registration number should be provided at the end of the Abstract. When a trial acronym is used, the registration number should also be stated at the first relevant mention where appropriate. Authors are responsible for ensuring consistency between the trial registration and the submitted manuscript and for explaining any discrepancies between information reported in the registry and in the manuscript.
Clinical trials must be pre-registered with an international clinical trials register and cite a reference to the registration in the Materials and Methods section. Suitable databases include clinicaltrials.gov, the EU Clinical Trials Register and those listed by the World Health Organization International Clinical Trials Registry Platform.
Adv Clin Exp Med reserves the right to decline any paper without trial registration for further peer review.
Authors' access to data
All authors should have the ability to review the data supporting study results. In the case of collaborations between authors from academic and nonacademic institutions, at least one author from the academic institution should have accessed the primary data and be able to participate in the analysis. With sponsored research, authors' access to the supporting data should be expressly provided for in any research agreements. Editors may ask which specific authors had access and participated in the analysis.
Data sharing
The rules for data sharing in Adv Clin Exp Med apply to all papers describing clinical trials: https://advances.umw.edu.pl/en/data-sharing.
CONSORT statement
Adv Clin Exp Med requires a completed CONSORT 2010 checklist and flow diagram as a condition of submission when reporting the results of a randomized trial. Templates for these can be found here or on the CONSORT website (http://www.consort-statement.org), which also describes several CONSORT checklist extensions for different designs and data types beyond two-group parallel trials. At a minimum, your article should report the content addressed by each checklist item.