Clinical Trials and Reporting Guidelines Policy

Clinical Trials Registration and Publication Policy

Avicenna Journal of Clinical and Translational Medicine

The Avicenna Journal of Clinical and Translational Medicine (AJCTM), published by Avicenna Medical Press (AMP), supports the responsible conduct, transparent registration, rigorous reporting and ethical publication of clinical trials.

This policy applies to interventional clinical research involving human participants and should be read alongside the journal's Research Ethics, Data Sharing and Reporting Guidelines policies.

1. Definition of a Clinical Trial

For registration purposes, AJCTM follows the ICMJE definition of a clinical trial: a research project that prospectively assigns individuals or groups to one or more health-related interventions to evaluate effects on health-related outcomes.

This may include pharmaceutical, surgical, device-based, behavioural, educational, rehabilitation, dietary and health-service interventions.

A concurrent control group is not required for a study to meet the definition of a clinical trial.

2. Prospective Trial Registration

AJCTM requires clinical trials to be registered in an acceptable, publicly accessible clinical trial registry at or before the time of first participant consent for enrollment.

The registry must meet current ICMJE requirements, including the applicable WHO trial registration data set.

Acceptable registries include ClinicalTrials.gov and primary registries within the WHO International Clinical Trials Registry Platform .

Ethics committee approval is essential where required but does not replace prospective trial registration.

3. Registration Information

Authors must provide the following information during manuscript submission:

• Official clinical trial registration number
• Name of the registering organization or registry
• Publicly accessible registration URL
• Date of initial registration
• Date of first participant enrollment
• Registered primary and secondary outcomes

The registration number and registry name should appear at the end of the abstract or in another clearly identified section specified by the journal.

4. Late or Retrospective Registration

Registration after participant enrollment does not satisfy the journal's standard prospective registration requirement.

Authors must disclose any late registration and explain the circumstances. Retrospective registration alone does not establish eligibility for publication.

Any exceptional editorial consideration will follow the applicable ICMJE guidance and will not be presented as equivalent to prospective registration.

5. Ethical Approval and Informed Consent

Clinical trials must have appropriate approval from a recognized research ethics committee or institutional review board before study commencement, where required by applicable regulations.

Authors must report the approving committee, approval reference number, approval date and informed consent procedures.

Trials must comply with applicable participant safety, privacy and research governance requirements.

6. Trial Protocol and Statistical Analysis

Authors should make the trial protocol and statistical analysis plan available to editors when requested.

Manuscripts must distinguish prespecified analyses from exploratory or post hoc analyses and explain important deviations from the registered protocol.

Changes to trial outcomes, eligibility criteria or analysis plans should be disclosed and justified.

7. Trial Reporting Standards

Reports of randomized controlled trials must follow the applicable CONSORT reporting guidance, including CONSORT 2025 and relevant extensions.

A completed reporting checklist and participant-flow diagram should be provided where applicable.

Trial protocols should follow applicable SPIRIT guidance.

8. Safety and Adverse Events

Clinical trial reports must describe important adverse events, harms, withdrawals and safety outcomes in a balanced and transparent manner.

Relevant monitoring arrangements, early stopping decisions and safety-related protocol changes should be reported where applicable.

9. Data Sharing and Transparency

Manuscripts reporting clinical trials must include an appropriate data sharing statement consistent with ICMJE recommendations and AJCTM's Data Sharing Policy.

Restrictions related to participant privacy, informed consent or legal requirements must be explained.

Authors should also disclose funding, sponsor involvement, conflicts of interest and access to the study data.

10. Negative and Inconclusive Findings

AJCTM evaluates scientifically valid clinical trials on the quality and importance of their research rather than the statistical significance or direction of their findings.

Negative, neutral and inconclusive results may be considered when the study addresses a relevant question and has been conducted and reported appropriately.

11. Editorial Assessment

Editors may request registration records, ethical approval documents, protocols, statistical analysis plans, or supporting records when necessary.

Concerns about trial registration, selective outcome reporting, research integrity or participant protection will be assessed under the journal's publication ethics procedures.

12. Guidance and Contact

ICMJE Recommendations
EQUATOR Network
ClinicalTrials.gov

Editorial Office, AJCTM
editor@ajctm.org