Trial reporting & publication

Reporting and publication is the final step in your trial pathway. Most biomedical journals require authors to comply with certain guidelines for reporting clinical trials. These guidelines are standard statements that provide guidance on how to report research methodology and findings. These guidelines are usually in the form of checklists, flow diagrams or texts. There are also some recommendations for improving the use of figures in reporting clinical trials.

The CONSORT Statement is an evidence-based, minimum set of recommendations for reporting randomized trials endorsed by most biomedical journals to improve the reporting of different types of health research and the quality of research used in decision-making in healthcare. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. It is one of the most commonly used statements for reporting clinical trials results. It contains a 25-item checklist and flow diagram, freely available for viewing and downloading through its website. In addition, extensions of the CONSORT Statement have been developed to give additional guidance for RCTs with specific designs, data and/or interventions.

The WHO Statement on Public Disclosure of Clinical Trial Results recommends that the Trial ID or registry identifier code/number is always to be included in all publications of clinical trials, and should be provided as part of the abstract to PubMed and other bibliographic search databases for easy linking of trial reports with clinical trial registry site records.

  1. The main findings of clinical trials are to be submitted for publication in a peer reviewed journal within 12 months of study completion and are to be published preferably through an open access mechanism, or otherwise made available publicly at most within 24 months of study completion.
  2. The key outcomes are to be made publicly available within 12 months of study completion by posting to the results section of the primary clinical trial registry. Where a registry is used without a results database available, the results should be posted on a free to-access, publicly available, searchable institutional website of the Regulatory Sponsor, Funder or Principal Investigator.

 

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