Clinical Trial Registration

Clinical Trial Registration Policy

Applied Health Research, Innovation & Education (AHRIE) promotes transparency, traceability, and responsible reporting of clinical trials. The journal applies the registration principles established by the World Health Organization (WHO) and draws on the recommendations of the International Committee of Medical Journal Editors (ICMJE), without representing itself as a member of that organization.

Definition of a Clinical Trial

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

Interventions may include medicines, biological products, devices, procedures, rehabilitation, educational or behavioral interventions, preventive strategies, changes in healthcare delivery, and other actions intended to modify a health outcome.

Prospective Registration

Clinical trials must be registered in a recognized public database before enrollment of the first participant. The registry must be freely accessible, uniquely identifiable, electronically searchable, and contain the internationally required minimum trial information.

AHRIE accepts registries included in the WHO International Clinical Trials Registry Platform Primary Registry Network and other registries recognized by the ICMJE, such as ClinicalTrials.gov.

Information Required in the Manuscript

Authors must provide:

• The name of the registry.

• The trial’s unique registration number.

• The public link to the registry record.

• The registration date.

• The date on which the first participant was enrolled.

• An explanation of any relevant differences between the registry record, protocol, and manuscript.

The registration number must appear at the end of the abstract and in the methods section of the manuscript.

Late or Retrospective Registration

Registration after enrollment of the first participant does not meet the principle of prospective registration. Manuscripts reporting late-registered trials will be considered only in exceptional circumstances and must clearly explain the reasons for the delay.

Retrospective registration does not guarantee that the manuscript will be sent for review or accepted. When AHRIE decides to consider such a study, its late-registration status must be transparently disclosed in the published article.

Updating the Registry Record

Authors are responsible for keeping the registry record current throughout the study. Changes to the protocol, primary or secondary outcomes, sample size, dates, sponsorship, or recruitment status must be promptly reflected in the registry and explained in the manuscript when relevant.

Registered outcomes must not be retrospectively changed for the purpose of making them conform to the findings obtained.

Protocols and Reporting Standards

Reports of randomized clinical trials must follow the current CONSORT guideline and include the corresponding checklist and flow diagram. Trial protocols must follow applicable SPIRIT recommendations.

AHRIE may request the complete protocol, statistical analysis plan, ethics approvals, consent forms, anonymized data, or other documentation necessary to verify the study’s integrity.

Secondary Analyses and Related Studies

Manuscripts reporting secondary analyses of a registered trial must identify the registry record and cite the primary publication when available. They must also clearly distinguish prespecified analyses from exploratory or post hoc analyses.

Observational Studies

Observational studies are not automatically considered clinical trials. However, AHRIE encourages their registration or preregistration when appropriate and requires compliance with any applicable legal, ethical, institutional, or funder requirements.

Registration and Ethics Approval

Public trial registration does not replace review and approval by a research ethics committee or the informed consent of participants. These requirements must be fulfilled and reported independently.

Noncompliance

Failure to register a trial, concealment of an existing registry record, unjustified discrepancies, or misleading alteration of registry information may result in suspension of the evaluation, rejection of the manuscript, or post-publication action.