👩‍🔬 Clinical Trials Covered by This Policy

For the purposes of this policy, a clinical trial includes research in which human participants or groups of participants are prospectively assigned to one or more health-related interventions to evaluate their effects on health outcomes.

Health-related interventions may include, but are not limited to:

• Drugs or medicinal products
• Biological products
• Surgical procedures
• Medical devices
• Diagnostic or therapeutic interventions
• Behavioural interventions
• Dietary interventions
• Educational interventions
• Preventive interventions
• Healthcare or process-of-care interventions

This approach is consistent with the current ICMJE definition of a clinical trial.

🧪 Prospective Registration

Clinical trials should be registered in a publicly accessible clinical trial registry before the enrollment of the first participant, or at the applicable time required by the relevant registration standards.

LQP considers prospective registration an important condition for consideration of clinical trial manuscripts for publication.

Registration after completion of participant enrollment or only at the time of manuscript submission does not provide the same transparency benefits as prospective registration.

The WHO also recommends registration of interventional clinical trials before the first participant is recruited.

🏛 Acceptable Trial Registries

Authors should register clinical trials in an appropriate, publicly accessible registry that meets recognized international standards.

LQP recognizes registries that are included in the WHO International Clinical Trials Registry Platform (ICTRP) Primary Registry Network or otherwise meet applicable ICMJE requirements.

Examples of recognized registries include:

• ClinicalTrials.gov
• Australian New Zealand Clinical Trials Registry (ANZCTR)
• ISRCTN Registry
• Chinese Clinical Trial Registry (ChiCTR)
• Clinical Trials Registry – India (CTRI)
• Other appropriate WHO ICTRP Primary Registries

The current ICMJE recommendations recognize public registration in a WHO ICTRP Primary Registry or ClinicalTrials.gov as acceptable for ICMJE purposes.

Authors should verify that the registry they use meets the requirements applicable to their study and jurisdiction.

🔍 Trial Registration Number

Authors must provide the trial registration number and the name of the clinical trial registry in the manuscript where applicable.

The registration information should be included in an appropriate section of the manuscript and should be clearly identifiable.

Where applicable, the trial registration number should also be included in the article abstract.

ICMJE recommends that journals publish the trial registration number at the end of the abstract.

⚖️ Information Provided at Submission

For manuscripts reporting clinical trial results, authors should provide:

• Trial registration number
• Name of the registration registry
• Date of registration, where relevant
• Information regarding prospective registration
• Any required explanation concerning delayed registration

LQP may verify the registration information against the publicly available registry record.

📌 Consistency Between Registry and Manuscript

Authors are responsible for ensuring that information reported in the manuscript is consistent with the registered trial information.

Where there are differences between the registered protocol and the manuscript, authors should clearly explain and justify substantial changes, including changes to:

• Primary outcomes
• Secondary outcomes
• Eligibility criteria
• Intervention
• Sample size
• Study design
• Analysis plan

Unexplained discrepancies may raise concerns regarding selective reporting or research integrity.

🔐 Ethics Approval Does Not Replace Trial Registration

Ethical approval and clinical trial registration are separate requirements.

Approval from an Institutional Review Board, Research Ethics Committee, or other ethics body does not by itself satisfy the requirement for prospective clinical trial registration.

Where applicable, authors must comply with both:

1. Appropriate ethical approval requirements; and
2. Clinical trial registration requirements.

ICMJE specifically states that ethics committee or institutional review approval does not fulfill its prospective clinical trial registration requirement.

🚫 Retrospectively Registered Trials

LQP strongly supports prospective registration.

Where a clinical trial was not prospectively registered, authors must provide a clear explanation of the circumstances and provide any available registration information.

Editors may determine whether the circumstances justify further consideration of the manuscript. Any exception to prospective registration should be rare and must be appropriately explained.

Failure to prospectively register a clinical trial may result in rejection of the manuscript where the registration requirement applies. ICMJE emphasizes the importance of prospective registration and indicates that exceptions should be rare.

🏛 Trial Registration and Secondary Analyses

Secondary analyses of data from an already registered clinical trial should generally identify and reference the registration number of the original or parent trial where applicable.

Authors should not create a misleading impression that a secondary analysis represents a separately registered clinical trial when it is based on an existing registered study.

📌 Registration of Trial Results

Authors are responsible for complying with applicable requirements concerning the reporting or updating of trial results in the relevant clinical trial registry.

Where appropriate, authors should update the registry record with the publication information after the study results have been published.

ICMJE encourages authors to update trial registration records with the full journal citation after publication.

🔍 Data Sharing

Where applicable, clinical trial manuscripts should comply with the LQP Data Sharing Policy and relevant ICMJE requirements concerning data sharing.

Authors should ensure that any data-sharing plan is consistent with:

• Participant consent
• Ethical approval
• Privacy requirements
• Applicable laws and regulations
• Trial registration information

ICMJE currently includes specific data-sharing requirements for manuscripts reporting clinical trial results.

📌 Registration and Peer Review

The editorial team may verify the clinical trial registration during initial screening or peer review.

Reviewers may also consider whether:

• The registered trial corresponds to the submitted manuscript
• The primary outcomes are appropriately reported
• Major protocol changes are adequately explained
• The registration information is complete and publicly accessible

Where significant discrepancies are identified, authors may be asked to provide clarification.

🔍 Failure to Register

If a manuscript that requires clinical trial registration has not been appropriately registered, LQP may:

• Request clarification from the authors
• Request evidence of registration
• Require appropriate registration where feasible
• Request an explanation for delayed registration
• Seek additional ethical or institutional documentation
• Reject the manuscript where registration requirements have not been met

The final decision will depend on the nature of the study, applicable requirements, timing of registration, and circumstances surrounding any failure to register.

📌 Fraudulent or Misrepresented Registration

Providing false, fabricated, misleading, or materially inaccurate clinical trial registration information is considered a serious publication ethics concern.

If LQP identifies evidence of fabricated or manipulated registration information, the matter may be investigated under the Research Misconduct Policy.

Where necessary, LQP may contact the relevant institution, registry, ethics committee, or other appropriate authority.

🔍 Post-Publication Concerns

If concerns about clinical trial registration are identified after publication, LQP may investigate the matter.

Depending on the nature and seriousness of the concern, appropriate action may include:

• Correction
• Editorial clarification
• Expression of Concern
• Retraction
• Other appropriate post-publication action

Such action will be considered in accordance with the LQP Research Misconduct Policy and Corrections and Retractions Policy.

📌 Authors' Responsibilities

Authors submitting clinical trial manuscripts to an LQP journal are responsible for:

• Determining whether their study requires registration
• Registering applicable trials prospectively
• Using an appropriate public registry
• Providing accurate registration information
• Including the registration number in the manuscript where applicable
• Ensuring consistency between the registered trial and the manuscript
• Explaining substantial changes or discrepancies
• Complying with applicable ethical and regulatory requirements
• Updating the registry record where appropriate

🔍 Applicability to LQP Journals

This Clinical Trial Registration Policy is a publisher-level policy of Lumina Quest Publishing (LQP) and applies to all journals currently published by LQP and any journals added to the LQP publishing program in the future.

LQP is committed to supporting prospective clinical trial registration, transparent reporting, responsible research, and the integrity of the clinical research record.