Clinical Trials Policy

The Herald of the National Children's Medical Center is committed to the ethical conduct, prospective registration, transparent reporting, participant protection, scientific validity, and responsible dissemination of clinical trials.

Clinical trials submitted to the journal must comply with applicable ethical, legal, regulatory, and scientific requirements, including the journal’s Research Ethics Policy, the World Medical Association Declaration of Helsinki (2024), applicable Good Clinical Practice requirements, and relevant reporting standards.

Where applicable to the type and regulatory context of the trial, investigators should follow ICH E6(R3) Good Clinical Practice, which is an international ethical, scientific, and quality standard intended to protect the rights, safety, and well-being of trial participants and support reliable results. The main ICH E6(R3) guideline was adopted in January 2025, with Annex 2 adopted in June 2026.

Definition of a Clinical Trial

For this policy, the journal follows the ICMJE definition of a clinical trial as a research project that prospectively assigns people or groups of people to a health-related intervention in order to evaluate its effect on a health outcome.

Interventions may include, among others:

  • medicines and biological products;
  • vaccines;
  • medical devices;
  • surgical procedures;
  • behavioural interventions;
  • educational interventions;
  • dietary interventions;
  • preventive interventions;
  • quality-improvement interventions;
  • process-of-care changes.

Clinical trials are not limited to pharmaceutical studies or commercially sponsored research.

Purely observational research is not classified as a clinical trial under the ICMJE definition because the intervention or exposure is not assigned prospectively by investigators. Such studies remain subject to the journal’s Research Ethics and Reporting Guidelines policies.

Ethics Approval

All clinical trials involving human participants must receive appropriate prospective review and approval from an independent research ethics committee, institutional review board, or equivalent competent body before the research begins where such approval is required.

The manuscript should state:

  • the name of the ethics committee or IRB;
  • the institution or jurisdiction;
  • approval number and date, where available;
  • relevant informed-consent arrangements;
  • parental or legally authorized representative permission, where applicable;
  • child assent, where applicable.

Ethics approval does not replace the requirement for prospective clinical-trial registration.

The Declaration of Helsinki 2024 requires research protocols to receive ethics-committee consideration and approval before research begins and requires important protocol amendments to receive appropriate review.

Informed Consent and Pediatric Safeguards

Participation in a clinical trial must be voluntary and based on appropriately obtained informed consent, except where a lawful and ethically approved exception applies.

For pediatric clinical trials, investigators must provide additional safeguards appropriate to the participant’s age, developmental capacity, clinical condition, and vulnerability.

Where applicable, this includes:

  • permission from a parent or legally authorized representative;
  • seeking the child’s assent in an age- and development-appropriate manner;
  • respecting ethically meaningful dissent;
  • minimizing physical, psychological, procedural, and privacy-related burdens;
  • using age-appropriate information materials;
  • protecting the participant’s developing autonomy.

Detailed requirements are provided in the journal’s Research Ethics Policy, including the sections on Children and Vulnerable Participants, Parental Permission and Child Assent, Informed Consent, Privacy and Confidentiality, and Risk–Benefit Assessment.

Prospective Trial Registration

Clinical trials must be prospectively registered in a publicly accessible clinical-trial registry before recruitment of the first participant.

This requirement is consistent with the Declaration of Helsinki 2024, which requires medical research involving human participants to be registered before recruitment of the first participant. ICMJE requires clinical trials to be registered at or before the time of first participant consent for enrollment.

Registration must occur independently of:

  • study phase;
  • intervention type;
  • commercial or non-commercial sponsorship;
  • single-centre or multicentre status;
  • investigator-initiated status;
  • whether the intervention involves a drug, device, surgery, behaviour, education, diet, or another health-related intervention.

Acceptable Trial Registries

For compliance with ICMJE requirements, the journal accepts registration in:

  • a WHO International Clinical Trials Registry Platform (ICTRP) Primary Registry meeting the required registration standards; or
  • ClinicalTrials.gov.

The registration must be publicly accessible and contain sufficiently informative registration data. ICMJE currently requires an acceptable registration to include the applicable minimum 24-item trial registration dataset.

The WHO ICTRP itself is a platform rather than a registry to which investigators directly submit trials; registration takes place through an appropriate Primary Registry or other acceptable registry.

Registration Information

The registry record should accurately reflect the planned trial and, as applicable, include:

  • trial title;
  • study design;
  • intervention and comparator;
  • eligibility criteria;
  • primary and secondary outcomes;
  • recruitment status;
  • anticipated and actual enrollment;
  • study dates;
  • sponsor and funding information;
  • responsible investigators;
  • data-sharing plan where required;
  • other mandatory registry elements.

Authors are responsible for maintaining the registry record and updating material changes in a timely manner.

The manuscript should state the registry name and registration number. The journal recommends that the registration number be presented at the end of the abstract, consistent with ICMJE guidance.

Retrospective or Delayed Registration

Registration performed only after recruitment has begun does not satisfy the normal requirement for prospective registration.

Retrospective registration at manuscript submission does not remove the original failure to register prospectively.

A trial that was not appropriately registered prospectively may be considered ineligible for publication.

In rare circumstances, an editor may consider whether exceptional circumstances justify further consideration. Such exceptions must not be routine.

Where an exception is made:

  • the trial must be registered;
  • the delayed registration must be disclosed;
  • authors must explain why registration was delayed;
  • the editor should transparently indicate why an exception was permitted.

ICMJE emphasizes that such exceptions should be rare and that failure to register prospectively places a trial at risk of being inadmissible for publication.

Protocol and Prospective Planning

Clinical trials should be conducted according to a scientifically and ethically approved protocol.

The protocol should clearly describe, as applicable:

  • objectives and hypotheses;
  • study design;
  • participant eligibility;
  • interventions and comparators;
  • outcomes;
  • sample-size considerations;
  • randomization and allocation procedures;
  • masking or blinding;
  • statistical analysis;
  • safety monitoring;
  • ethical considerations;
  • data management;
  • post-trial provisions.

The Declaration of Helsinki requires the design and conduct of medical research to be clearly described and justified in a research protocol.

Protocol Amendments and Deviations

Authors must distinguish between protocol amendments and protocol deviations.

Material amendments to the planned trial should receive appropriate ethics or regulatory review where required and should be reflected in the trial registry when they affect registered information.

Authors should transparently report important deviations from the approved or registered protocol, particularly those involving:

  • eligibility criteria;
  • interventions;
  • primary or secondary outcomes;
  • sample size;
  • recruitment;
  • analysis;
  • participant safety;
  • trial termination.

The reason for a material change and its potential effect on interpretation should be explained.

Undisclosed outcome switching or retrospective alteration of trial objectives to match observed results is unacceptable.

Prespecified Outcomes and Analysis

Primary and secondary outcomes should be prospectively defined.

Published outcomes should be consistent with the protocol and trial registration.

If outcomes, statistical analyses, or other major methodological elements were changed after trial commencement, authors must:

  • identify the change;
  • state when it was made;
  • explain why it was made;
  • distinguish prospective changes from post hoc analyses.

Post hoc analyses may be scientifically useful but must be clearly identified as such.

Reporting Standards

Randomized clinical trials should be reported in accordance with the CONSORT 2025 Statement and relevant extensions.

CONSORT 2025 is the current general reporting guideline for randomized trials and contains a 30-item checklist and participant flow diagram.

Because the journal specializes in Pediatrics, Perinatology and Child Health, randomized trials involving children and adolescents should also use the CONSORT-Children and Adolescents (CONSORT-C) 2026 extension where applicable.

CONSORT-C 2026 was developed specifically for pediatric randomized trials involving participants aged 0–19 years and adds pediatric-specific reporting requirements to CONSORT 2025.

Where an eligible randomized-trial protocol manuscript is submitted, authors should follow SPIRIT 2025 and, for pediatric protocols, SPIRIT-Children and Adolescents (SPIRIT-C) 2026 where applicable.

Completed checklists and flow diagrams may be requested as part of submission or editorial review.

Safety and Adverse Events

Clinical-trial reports must present safety information accurately, completely, and without selective omission.

Where applicable, authors should describe:

  • expected and unexpected adverse events;
  • serious adverse events;
  • withdrawals related to adverse events;
  • safety-monitoring procedures;
  • stopping or modification criteria;
  • relevant interim analyses;
  • the role of any independent data or safety monitoring body.

The intensity of safety monitoring should be proportionate to the intervention and participant risk.

A Data and Safety Monitoring Board is not automatically required for every clinical trial, but appropriate independent safety oversight should be used where the study design, population, intervention, or risk warrants it.

Serious safety concerns must not be concealed because they are inconsistent with the study hypothesis or sponsor interests.

Placebo and Control Groups

Choice of comparator must be scientifically and ethically justified.

Under the Declaration of Helsinki 2024, new interventions should generally be tested against the best proven intervention.

Placebo or no intervention may be ethically acceptable where no proven intervention exists, or where compelling scientifically sound methodological reasons justify its use and participants are not exposed to additional risk of serious or irreversible harm from withholding the best proven intervention.

Particular caution is required in pediatric and other vulnerable populations.

Early Termination

Prematurely stopped or suspended trials must be reported transparently.

Authors should disclose:

  • who made the decision;
  • when the decision was made;
  • the reason for stopping;
  • participant numbers at termination;
  • relevant safety or efficacy findings;
  • whether the registry status was updated.

Stopping a trial early for benefit, harm, futility, recruitment difficulty, funding reasons, or other causes should not be concealed.

Authors’ Access to Trial Data

Authors must have sufficient access to the data supporting the reported results to accept responsibility for the work.

ICMJE’s January 2026 Recommendations state that all authors should be able to review the data supporting study results. In academic–non-academic collaborations, at least one academic author should have accessed the primary data and be able to participate in the analysis. Sponsored-research agreements should explicitly preserve appropriate author access to supporting data.

Editors may request information about which authors had access to primary data and participated in analysis.

Sponsor and Funder Role

The role of the sponsor, funder, contract research organization, or other relevant partner must be transparently disclosed.

The manuscript should state, where applicable, the sponsor’s role in:

  • protocol development;
  • study design;
  • recruitment;
  • data collection;
  • data management;
  • statistical analysis;
  • interpretation;
  • manuscript preparation;
  • the decision to submit for publication;
  • data sharing.

Sponsor agreements must not prevent investigators from accessing relevant data, independently interpreting the findings, or publishing scientifically valid results.

Clinical Trial Data Sharing

Manuscripts reporting clinical-trial results must contain a data-sharing statement consistent with the journal’s Research Data Policy.

ICMJE requires clinical-trial manuscripts to state whether de-identified individual participant data will be shared, what data and related documents will be available, when and for how long, and under what access conditions.

Trials beginning participant enrollment on or after 1 January 2019 must also include a data-sharing plan in their registration. Material changes to that plan should be updated in the registry and manuscript.

The journal does not interpret this requirement as requiring unrestricted public disclosure of identifiable or inadequately de-identified pediatric health data.

Post-Trial Provisions

Post-trial responsibilities must be considered during trial planning.

The Declaration of Helsinki 2024 requires sponsors and researchers, before a clinical trial begins, to arrange appropriate post-trial provisions for participants who continue to need an intervention shown in the trial to be beneficial and reasonably safe. Exceptions require ethics-committee approval, and relevant information must be included in the informed-consent process.

The nature of post-trial arrangements should be proportionate to the intervention, clinical context, participant needs, and applicable ethical and legal requirements.

Publication and Dissemination of Results

Positive, negative, and inconclusive results should be reported honestly and transparently.

Selective non-publication of unfavorable findings, selective outcome reporting, or suppression of safety findings is inconsistent with responsible clinical-trial publication.

The Declaration of Helsinki 2024 places ethical obligations on researchers, authors, sponsors, editors, and publishers concerning timely and accurate dissemination of research results and states that positive, negative, and inconclusive results should be made publicly available.

Trial-registry records should also be updated as required by applicable registry, funder, and regulatory requirements.

Secondary Analyses

Secondary analyses of a previously registered parent trial should identify and cite the original trial registration number.

ICMJE does not require a secondary analysis of a parent clinical trial to be registered as a separate new clinical trial solely because a new analysis is being performed.

Authors must clearly identify the work as a secondary analysis and explain how it differs from previously reported analyses.

Use of shared trial data must comply with the applicable data-sharing conditions and appropriately credit the original dataset.

Editorial Verification

The journal may compare the submitted manuscript with:

  • the trial registry;
  • protocol;
  • statistical analysis plan;
  • ethics documentation;
  • data-sharing statement;
  • previous publications from the same trial.

Editors may request clarification regarding discrepancies in recruitment dates, outcomes, sample size, interventions, analysis, registration status, safety information, or other material elements.

Peer review does not replace the authors’ responsibility for accurate registration and reporting.

Non-Compliance and Editorial Action

Potential concerns include:

  • failure to register prospectively;
  • false or misleading trial registration;
  • fabricated registration information;
  • undisclosed protocol changes;
  • unexplained outcome switching;
  • inconsistent registry and manuscript information;
  • missing ethics approval;
  • inadequate consent or pediatric safeguards;
  • concealment of adverse events;
  • manipulation of trial data;
  • inappropriate sponsor interference;
  • misleading data-sharing information.

Depending on the circumstances, the journal may request clarification or documentation, suspend consideration, seek independent advice, reject the manuscript, contact an appropriate institution or ethics body, or take post-publication action.

Such matters are handled in conjunction with the journal’s Publication Ethics, Research Ethics, Research Data Policy, Corrections and Retractions Policy, and Ethical Non-Compliance and Editorial Action procedures.

Policy Application

This policy applies to manuscripts reporting clinical trials submitted to the journal regardless of intervention type, sponsor, funding source, institution, country, or whether the trial is commercially or investigator initiated.

The purpose of this policy is to ensure that clinical trials published by the journal are ethically conducted, prospectively registered, scientifically sound, transparently reported, appropriately monitored, and respectful of the rights, safety, and welfare of participants—especially children and other vulnerable populations.

ISSN 2181-3353 (Print)
ISSN 2181-3353 (Online)