Clinical Research

What to submit

Communications Medicine considers primary research studies that represent a significant advance in preventing, diagnosing or treating human disease of relevance to a specialized field.

We consider all types of clinical research, including:

  • case-reports and small case series
  • clinical trials (phase 1 to 4)
  • observational studies
  • biomarker studies
  • systematic reviews and meta-analyses
  • public and global health studies

Preparing your submission

Communications Medicine 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 reporting of clinical studies.

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 the context of a clinical trial (e.g. compassionate use) authors must provide a statement with details about ethics approval and confirming that participants gave written informed consent, according to CARE guidelines and in compliance with the principles of Declaration of Helsinki.
  • Randomized controlled trials must conform to CONSORT 2010 guidelines, and the CONSORT checklist should be submitted with the manuscript and 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 peer review.
  • Reporting of clinical trials evaluating interventions with an Artificial Intelligence 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.
  • 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.
  • Observational studies (cohort, case-control or cross-sectional designs) must be reported according to the STROBE statement.
  • Epidemiological studies reporting health estimates should follow the recommendations in the GATHER statement.
  • Systematic reviews and meta-analyses must follow the PRISMA guidelines and be prospectively registered in PROSPERO.

Registration

All interventional clinical trials must be registered before enrollment of the first participant. Trial registration records must be available in a primary registry 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 by Communications Medicine.

Study protocol

To enable proper assessment of the work by the editors and referees, Communications Medicine requests that a copy of the approved study protocol, including the statistical analysis plan, is provided with all submitted clinical trial manuscripts. 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 the intended number of patients, inclusion and exclusion criteria, pre-specified primary and secondary outcomes, as well as start and completion date. Any deviations from the plan indicated in the trial registry or study protocol must be explained transparently in the manuscript.

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.

Data sharing

In accordance with Nature Portfolio editorial policy, a Data Availability Statement (DAS) must be included with all original research manuscripts. Communications Medicine 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 submitted to Communications Medicine 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 Portfolio 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.