SPIRIT 2013 Statement

The SPIRIT 2013 statement was an international collaboration to develop clear and comprehensive guidance for preparing a full protocol for a clinical trial. The statement continues to evolve with extensions to enhance research protocol development in numerous areas.

Although a comprehensive and detailed protocol is an essential component of high-quality research, significant issues have been identified with many available protocols. For example, protocols have often failed to include information on randomization and allocation concealment processes, have not distinguished between primary and secondary outcomes, have not provided power calculations for the planned analyses, have not included plans for analyses that were reported in subsequently published study papers, or have not explicitly noted possible conflicts of interest for researchers and/or funders. A protocol that lacks full transparency is ...

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