Clinical Research | Nature Portfolio

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class="container cleared container-type-title" data-container-type="title"> <h1 class="tighten-line-height small-space-below">Clinical Research </h1> </div> <div class="container cleared container-type-body-content wysiwyg" data-container-type="body-content"> <p><em>Nature</em> follows the recommendations from the International Committee of Medical Journal Editors (<a href="http://www.icmje.org/">ICMJE</a>) and the Enhancing the QUAlity and Transparency Of health Research (<a href="http://www.equator-network.org/">EQUATOR</a>) Network for registration and reporting clinical studies.</p> <p><em>Registration</em></p> <p>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 (<a href="http://apps.who.int/trialsearch/">ICTRP</a>), in <a href="https://clinicaltrials.gov/">ClinicalTrials.gov</a>, or in any publicly accessible database that meets the minimum <a href="http://www.who.int/ictrp/network/trds/en/index.html">24-item trial registration dataset</a>.</p> <p>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.</p> <p><em>Study protocol</em></p> <p>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, be included with the initial submission. Sensitive content can be redacted. If the original protocol is in a language other than English, a translation should be provided. Any deviations from the plan indicated in the trial registry or study protocol must be justified.</p> <p><em>Interim analyses</em></p> <p>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. Unplanned post-hoc or exploratory analyses should be clearly indicated as such in the abstract and manuscript text.</p> <p><em>Reporting guidelines</em></p> <ul> <li>Case reports or case series – if performed in the setting of a clinical trial evaluating effectiveness in a single patient, a <a href="https://www.equator-network.org/reporting-guidelines/consort-cent/">CONSORT extension for N-of-1 trials</a> 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 <a href="https://www.care-statement.org/">CARE guidelines</a> and in compliance with the Declaration of Helsinki principles.</li> <li>Randomized trials must conform to <a href="https://www.equator-network.org/reporting-guidelines/consort/">CONSORT 2010 guidelines</a>, and the CONSORT checklist should be submitted with the manuscript and other materials, including the 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.</li> <li>Observational studies (cohort, case–control or cross-sectional designs) must be reported according to the <a href="https://strobe-statement.org/index.php?id=strobe-home">STROBE statement</a>.</li> <li>Systematic reviews and meta-analyses must follow the <a href="http://www.prisma-statement.org/">PRISMA</a> guidelines.</li> <li>Studies reporting biomarkers in association with clinical outcomes should follow the <a href="http://www.equator-network.org/reporting-guidelines/stard/">STARD</a> guidelines. For biomarker studies in oncology, we request that authors adhere to <a href="https://www.equator-network.org/reporting-guidelines/reporting-recommendations-for-tumour-marker-prognostic-studies-remark/">REMARK</a> guidelines.</li> <li>Epidemiology studies are encouraged to follow the recommendation in the <a href="http://gather-statement.org/">GATHER</a> statement.   </li> </ul> <p><em>Data sharing</em></p> <p>In accordance with Nature Research policy, a Data Availability Statement (DAS) must be included with all original research manuscripts. Nature is committed to transparency in data availability, and we request that authors provide a clear statement summarizing what data is available, when and to whom, and how to access it, and clearly stating any restrictions to data access.</p> <p>Following ICMJE recommendations, clinical trials that began enrolling participants 1 January 2019 and later must include a data sharing plan in the trial's registration. 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.</p> <p><em>Competing interests</em></p> <p>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. 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