SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

TLDR

High‑quality protocols facilitate proper conduct, reporting, and external review of clinical trials, yet protocol completeness is often inadequate. The paper aims to improve protocol quality by developing the SPIRIT 2013 Statement and providing explanatory guidance to promote full understanding of its checklist. The authors present the SPIRIT Statement as a checklist of recommended protocol items, supplemented with rationale, detailed descriptions, model examples, and supporting references for each item. Using the explanatory paper alongside the SPIRIT Statement should aid protocol drafting, enhance transparency, and facilitate review for all stakeholders. Resources are available at www.spirit-statement.org.

Abstract

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.