Clinical Trial Registration Policy

Last Updated: April 2026

In accordance with ICMJE, WHO, and COPE guidelines, all clinical trials must be prospectively registered in a publicly accessible registry. The journal defines a clinical trial as any research study that prospectively assigns human participants to health-related interventions, including drugs, surgical procedures, behavioral treatments, and devices, to evaluate subsequent health outcomes.

Acceptable Registries

Authors are required to register their trials in a primary registry that participates in the WHO International Clinical Trials Registry Platform (ICTRP) or via ClinicalTrials.gov. Commonly accepted registries include ClinicalTrials.gov, ISRCTN, the EU Clinical Trials Register, and the Chinese Clinical Trial Registry. For a comprehensive and up-to-date list of all approved registries, authors should consult the official WHO ICTRP portal.

Timing and Submission Requirements

All trials must be registered before the enrollment of the first participant to ensure prospective transparency. While retrospective registration is occasionally documented, it requires a robust justification letter and is subject to rigorous editorial review. Upon submission, authors must explicitly state the Trial Registration Number, the formal name of the registry, and provide a direct link to the publicly available entry within the manuscript.

Data Sharing and Protocol Transparency

In alignment with the latest ICMJE requirements, authors must include a Data Sharing Statement indicating whether individual de-identified participant data will be shared, what specific data will be available, and the criteria for access. Furthermore, for all randomized controlled trials, the original study protocol (including the statistical analysis plan) must be submitted alongside the manuscript. Any subsequent amendments to the protocol during the course of the study must be clearly documented and explained to ensure the integrity of the predefined endpoints.

Reporting of Results and Guidelines

Manuscripts reporting the results of clinical trials must adhere strictly to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. It is mandatory for authors to provide a completed CONSORT checklist and a participant flow diagram as part of their submission. Additionally, the journal strongly encourages authors to ensure that the summary of results is posted in the relevant trial registry within one year of study completion, as mandated by many international regulatory bodies.

Compliance and Enforcement

Adherence to these registration and reporting standards is a prerequisite for publication. Non-compliance with these policies, including failure to disclose any discrepancies between the registered registry entry and the final submitted results, may result in the immediate rejection of the manuscript. Any exceptions to these requirements are extremely rare and are granted only at the sole discretion of the Editor-in-Chief.