Improving The Completeness Of Trial Protocols With New Guidelines

Main Category: Clinical Trials / Drug Trials
Article Date: 09 Jan 2013 - 0:00 PST


A panel of experts has released a new 33-item protocol checklist focusing on clarifying the content of clinical trials.

While the protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal, trial protocols and existing protocol guidelines vary greatly in content and quality.

Adherence to SPIRIT would enhance the transparency and completeness of trial protocols and could help ensure that protocols contain the requisite information for critical appraisal and interpretation. High-quality protocols can provide important information about trial methods and conduct that is not available from journals or trial registries. As a transparent record of the researchers' original intent, comparisons of protocols with final trial reports can help to identify selective reporting of results and undisclosed amendments, such as changes to primary outcomes.

According to the authors, pilot-testing and informal feedback of the SPIRIT guideline has shown that it is particularly valuable for trial investigators when they draft their protocols and can also serve as a training tool for new investigators, peer reviewers, and research ethics committee members or institutional review board members. There is also potential benefit for trial implementation.

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