Clinical research

What to submit

In keeping with the journal mission, Nature Communications is interested in publishing high-quality research that represents important advances of significance to communities of researchers and clinicians.

The journal will consider articles reporting influential research in all areas of medical research, from translational medicine to clinical practice as well as studies of importance to health related matters. The journal is particularly interested in publishing clinical trials, including trials with negative results of high relevance to a particular community as well as pilot and feasibility trials.

We consider all types of clinical research, including

  • Case-reports and small case series
  • Clinical trials, whether phase 1, 2, 3 or 4
  • Observational studies
  • Meta-analyses
  • Systematic reviews
  • Biomarker studies   
  • Public and global health studies

In addition to the above, Nature Communications remains interested in submissions reporting preclinical and translational findings. All clinical studies described above can be submitted as regular articles.

Preparing your submission

Nature Communications follows the recommendations from the International Committee of Medical Journal Editors (ICMJE) and the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network for registration and reporting clinical studies.

Registration

All interventional trials must be registered before enrollment of the first participant. Trial registration records must be available in a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), in ClinicalTrials.gov, or in any publicly accessible database that meets the minimum 24-item trial registration dataset.

The trial number must be clearly indicated in the abstract and methods section of the manuscript. Trials with retrospective registration or with registration in a database that is not publicly accessible cannot be considered.

Study protocol

To enable proper assessment of the work by our editorial team and referees, we request that a copy of the approved study protocol, including the statistical analysis plan, is provided with the submitted manuscript. Sensitive content can be redacted. If the original protocol is in a language other than English, a translation should be provided. The translation should include at the minimum, details on the design of the study, including intended number of patients, inclusion/exclusion criteria, prespecified primary/secondary outcomes, start and completion date. Any deviations from the plan indicated in the trial registry or study protocol must be justified.

Interim analyses

Interim analyses should be pre-specified in the study protocol. Preliminary analyses of ongoing clinical trials that have not been pre-specified must be justified and are considered on a case-by-case basis. The editors may require evidence that the data safety monitoring board has agreed to the release of the data for publication. Unplanned post-hoc or exploratory analyses should be clearly indicated as such in the abstract and manuscript text.

Reporting guidelines

  • Case reports or case series – if performed in the setting of a clinical trial evaluating effectiveness in a single patient, a CONSORT extension for N-of-1 trials must be provided; if treatment is provided outside a clinical trial (e.g., as compassionate use, or experimental observational study), authors must provide a statement that the research protocol was approved by IRB and ethics committees and participants gave written informed consent, according to CARE guidelines and in compliance with the Declaration of Helsinki principles.
  • Randomized trials must conform to CONSORT 2010 guidelines, and the CONSORT checklist should be submitted with the manuscript and other materials, including the study protocol. Non-randomized trials are encouraged to use the CONSORT principles and framework in the reporting of the results. Reports that do not conform to the CONSORT guidelines may need to be revised before formal review.
  • Reporting for clinical trials evaluating interventions with an Artificial Intelligence (AI) component must conform to the guidelines of the CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension. These items should be routinely reported in addition to the core CONSORT 2010 items. The complete checklist should be submitted with the manuscript.
  • Reporting of protocols for clinical trials evaluating interventions with an Artificial Intelligence (AI) component must conform to the guidelines of the SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials) extension. These items should be routinely reported in addition to the core SPIRIT 2013 items. The complete checklist should be submitted with the manuscript.
  • Observational studies (cohort, case-control or cross-sectional designs) must be reported according to the STROBE statement.
  • Systematic reviews and meta-analyses must follow the PRISMA guidelines. We strongly encourage prospective registration of systematic reviews in PROSPERO.
  • Studies reporting biomarkers in association with clinical outcomes should follow the STARD guidelines. For biomarker studies in oncology, we request that authors adhere to REMARK guidelines.
  • Epidemiology studies are encouraged to follow the recommendation in the GATHER statement.   

Data sharing

In accordance with Nature Research policy, a Data Availability Statement (DAS) must be included with all original research manuscripts. Nature Communications is committed to transparency in data availability, and we request that authors provide a clear statement summarizing what data is available, under what circumstances it can be accessed and clearly stating any restrictions to access and use.

Following ICMJE recommendations, clinical trials that began enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial's registration information. If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

Competing interests

In the interests of transparency and to help readers form their own judgments of potential bias, Nature Research journals require authors to declare any competing financial and/or non-financial interests in relation to the work described. The corresponding author is responsible for submitting a competing interests statement on behalf of all authors of the paper.

The role of the sponsor in any stage of the study, including in study design, data analysis or manuscript preparation, must be acknowledged.