Table 2.
Potential Benefits and Proposed Stakeholder Actions for Supporting Adherence to SPIRIT 2013
Stakeholder | Proposed Actions | Potential Benefits |
---|---|---|
Clinical trial groups, investigators, sponsors | Adopt SPIRIT as standard guidance Use as tool for writing protocols |
Improved quality, completeness, and consistency of protocol content Enhanced understanding of rationale and issues to consider for key protocol items Increased efficiency of protocol review |
Research ethics committees/institutional review boards, funding agencies, regulatory agencies | Mandate or encourage adherence to SPIRIT for submitted protocols Use as training tool |
Improved quality, completeness, and consistency of protocol submissions Increased efficiency of review and reduction in queries about protocol requirements |
Educators | Use SPIRIT checklist and explanatory paper as a training tool | Enhanced understanding of the rationale and issues to consider for key protocol items |
Patients, trial participants, policymakers | Advocate use of SPIRIT by trial investigators and sponsors | Improved protocol content relevant to transparency, accountability, critical appraisal, and oversight |
Trial registries | Encourage SPIRIT-based protocols Register full protocols to accompany results disclosure |
Improved quality of registry records Prompt for trialists to update registry record when SPIRIT checklist item 2b (Registration Data Set) is updated Improved quality, completeness, and consistency of protocol content for registries that house full protocols and results |
Journal editors and publishers | Endorse SPIRIT as standard guidance for published and unpublished protocols Include reference to SPIRIT in instructions for authors Ask that protocols be submitted with manuscripts, circulate them to peer reviewers, and encourage authors to make them available as Web appendices |
Improved quality, completeness, and consistency of protocol content Enhanced peer review of trial manuscripts through improved protocol content, which can be used to assess protocol adherence and selective reporting Improved transparency and interpretation of trials by readers |
SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials.