5. Clinical Trial Registration

Purpose

The Pakistan Journal of Gastroenterology (PJG) supports the prospective registration of clinical trials to promote research transparency, participant safety, scientific integrity, and public trust. Registration of clinical trials helps prevent selective reporting, publication bias, and duplication of research while ensuring public access to essential trial information.

The Journal follows the recommendations of the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), and the Committee on Publication Ethics (COPE).

5.1 Registration Requirement

All clinical trials submitted to the Journal must be registered in a publicly accessible, internationally recognized clinical trial registry before the enrollment of the first participant.

Prospective registration is strongly encouraged and is considered an essential component of ethical clinical research.

5.2 Acceptable Clinical Trial Registries

The Journal accepts registration in registries that meet the standards of the WHO International Clinical Trials Registry Platform (ICTRP) or are recognized by the ICMJE.

Examples include:

  • ClinicalTrials.gov
  • ISRCTN Registry
  • EU Clinical Trials Register
  • Australian New Zealand Clinical Trials Registry (ANZCTR)
  • Chinese Clinical Trial Registry (ChiCTR)
  • Iranian Registry of Clinical Trials (IRCT)
  • Clinical Trials Registry – India (CTRI)
  • Pan African Clinical Trial Registry (PACTR)
  • Any WHO ICTRP Primary Registry

5.3 Registration Information

Authors must provide the following information during manuscript submission:

  • Name of the clinical trial registry.
  • Trial registration number.
  • Date of registration.
  • Registration URL (where applicable).

The registration number should also be included in the manuscript, preferably at the end of the Abstract or within the Methods section.

5.4 Definition of a Clinical Trial

For the purposes of this policy, a clinical trial is any research study that prospectively assigns one or more human participants or groups to one or more health-related interventions in order to evaluate their effects on health outcomes.

Interventions may include:

  • Drugs or medications.
  • Surgical procedures.
  • Medical devices.
  • Behavioral interventions.
  • Dietary interventions.
  • Rehabilitation therapies.
  • Preventive strategies.
  • Diagnostic procedures.

5.5 Retrospective Registration

The Journal strongly prefers prospective registration. Manuscripts describing retrospectively registered clinical trials may be considered only in exceptional circumstances.

Authors must provide a clear explanation for delayed registration. Acceptance of retrospectively registered trials remains at the discretion of the Editor-in-Chief and the Editorial Board.

5.6 Non-Clinical Studies

This policy does not apply to:

  • Narrative reviews.
  • Systematic reviews and meta-analyses.
  • Case reports and case series.
  • Editorials.
  • Letters to the Editor.
  • Laboratory-based experimental studies.
  • Animal studies.
  • Bioinformatics or computational studies without prospective human intervention.

However, these studies must comply with all other applicable ethical requirements.

5.7 Editorial Verification

The Editorial Office may verify:

  • The authenticity of the registration record.
  • The registration date.
  • Consistency between the registered protocol and the submitted manuscript.
  • Any discrepancies between registered outcomes and reported results.

Authors may be asked to provide additional documentation where necessary.

5.8 Failure to Register

Failure to register a clinical trial in accordance with this policy may result in:

  • Requests for clarification.
  • Delays in editorial processing.
  • Rejection of the manuscript.
  • Publication of an editorial note where appropriate.

The Journal reserves the right to decline manuscripts that do not comply with internationally accepted clinical trial registration standards.

5.9 Author Responsibility

The Corresponding Author is responsible for ensuring that:

  • The trial has been appropriately registered.
  • Registration information provided during submission is accurate and complete.
  • The manuscript accurately reflects the registered study protocol.
  • Any deviations from the registered protocol are fully disclosed and justified.

References

This policy has been developed in accordance with:

  • International Committee of Medical Journal Editors (ICMJE) Recommendations.
  • World Health Organization (WHO) – International Clinical Trials Registry Platform (ICTRP).
  • Committee on Publication Ethics (COPE) Core Practices.
  • Declaration of Helsinki (latest revision).