Clinical Trial Registration Policy

Clinical Trial Registration Policy

At Medical and Pharmaceutical Journal, we are committed to promoting transparency, accountability, and the highest ethical standards in clinical research. To ensure compliance with international guidelines, the following policy outlines our requirements for the registration of clinical trials.

1. Mandatory Registration

All clinical trials submitted to our journal must be registered in a publicly accessible, recognized clinical trial registry before the enrollment of the first participant. Acceptable registries include, but are not limited to:

  • ClinicalTrials.gov (U.S. National Library of Medicine).
  • WHO International Clinical Trials Registry Platform (ICTRP).
  • EU Clinical Trials Register.
  • Registries that are part of the WHO Registry Network or approved by the International Committee of Medical Journal Editors (ICMJE).

2. Definition of a Clinical Trial

We define a clinical trial as any research study that prospectively assigns human participants or groups to one or more health-related interventions (e.g., drugs, devices, procedures, or behavioral therapies) to evaluate their effects on health outcomes.

3. Registration Information

The trial registry entry must include the following:

  • Unique trial registration number.
  • Descriptive title and brief title.
  • Names and affiliations of principal investigators.
  • Sponsor information.
  • Study design and methodology.
  • Description of interventions and comparators.
  • Primary and secondary outcome measures.
  • Participant eligibility criteria (inclusion and exclusion).
  • Anticipated enrollment size.
  • Dates of trial commencement and expected completion.

4. Manuscript Requirements

  • The trial registration number and registry name must be included in both the abstract and methods section of the manuscript.
  • Manuscripts must follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines for clinical trial reporting to ensure accuracy and transparency.

5. Ethical Considerations

  • Authors must confirm that the trial received ethical approval from a recognized Institutional Review Board (IRB) or Ethics Committee.
  • Evidence of ethical approval (e.g., an approval letter or certificate) must be submitted alongside the manuscript.

6. Retrospective Registration

Trials that began before mandatory registration policies were in place may be considered if they are registered retrospectively. Authors must provide a detailed explanation of the timing of registration and ensure the registry entry is complete.

7. Non-Compliance

Submissions that fail to meet the clinical trial registration requirements will not be considered for publication. Non-compliance discovered post-publication may lead to retraction.

8. Updates and Post-Publication Amendments

Authors are encouraged to update their trial registry entries with significant changes or results. The journal must be notified of any updates that occur after publication to maintain transparency.