Clinical trial registration
General information
The ICMJE defines as clinical trial any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
The purpose of clinical trial registration is to prevent selective publication and selective reporting of research outcomes, to prevent unnecessary duplication of research effort, to help patients and the public know what trials are planned or ongoing into which they might want to enroll, and to help give ethics review boards considering approval of new studies a view of similar work and data relevant to the research they are considering. Retrospective registration, e.g. at the time of manuscript submission, meets none of these purposes. Secondary data analyses of primary (parent) clinical trials should not be registered as separate clinical trials, but instead should reference the trial registration number of the primary trial.
Registration
Adv Clin Exp Med follows the International Committee of Medical Journal Editors (ICMJE) guidelines, which require and recommend registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
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.
Authors are strongly encouraged to pre-register clinical trials 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.
Approval to conduct a study from an independent local, regional, or national review body is not equivalent to prospective clinical trial registration. Adv Clin Exp Med reserves the right to decline any paper without trial registration for further peer review. However, if the study protocol has been published before the enrolment, the registration can be waived with correct citation of the published protocol.
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.
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.