Allow SPIRIT to Pave Your Path Toward a Successful Clinical Trial

A clinical trial is one type of research study that provides high-level of evidence by testing new interventions in participants. Previously, we introduced the Consolidated Standards of Reporting Trials (CONSORT) statement that is used to ensure a transparent and accurate reporting of the study results from a clinical trial. Here, we discuss the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement that provides a guideline to formulate a clinical trial protocol.

What is the SPIRIT statement?

Every clinical trial starts from a study protocol. A high-quality study protocol outlines the background, rationale, hypothesis, design, materials, methods, participants, outcome measurements, statistical analysis, ethical consideration, and timeline of a clinical trial. The development of a study protocol serves as a foundation for the study planning, execution, reporting, and external evaluations.

In January 2013, the SPIRIT statement was published, which provides an evidence-based guidance to structure a clinical trial protocol and improve the completeness and quality of a clinical trial study. Since its publication, the SPIRIT statement has been endorsed by more than 200 international journals and organizations and has been translated into seven languages.

What is the purpose of the SPIRIT statement?

The use of a SPIRIT statement can improve the validity, reliability, transparency, and accountability of a clinical trial. It can remind investigators about important items to include during trial design and suggest a path to achieve these goals. It can not only serve as a framework to develop a trial protocol, but also provide a template to finalize a trial protocol for ethical approval, online registration, and publication.

What are included in the SPIRIT statement?

The SPIRIT Statement includes a 33-item checklist and a diagram. The 33-item checklist defines the minimum essential requirements for a clinical trial protocol. The diagram outlines the timeline and scheduled tasks of a clinical trial. The SPIRIT explanation and elaboration documents provide detailed descriptions, rationale, and examples for all items that are important during the trial design and execution. In addition, several specialized extensions to the SPIRIT statement have been developed to accommodate different requirements from various subtypes of trial designs, data process, and clinical interventions.

What are the differences between SPIRIT and CONSORT statements?

Many items in the SPIRIT statement overlap with the items in CONSORT statement. The format of the SPIRIT statement is also similar to that of the CONSORT statement. However, these two statements have important differences:



Researchers preparing for a clinical trial should familiarize themselves with both SPIRIT and CONSORT statements. Adherence to both statements can facilitate a smooth path from an initial SPIRIT-guided trial protocol creation to a final CONSORT-guided trial result publication.