31 October 2013 | An-Wen Chan, Jennifer M Tetzlaff, Peter C Gøtzsche, Douglas G Altman, Howard Mann, Jesse A Berlin, Kay Dickersin, Asbjørn Hróbjartsson, Kenneth F Schulz, Wendy R Parulekar, Karmela Krleža-Jerici, Andreas Laupacis, David Moher
The SPIRIT 2013 Statement provides guidance for clinical trial protocols, aiming to improve their completeness and quality. It includes a checklist of recommended items and an accompanying Explanation and Elaboration paper that provides detailed descriptions, rationale, and examples for each checklist item. The SPIRIT Initiative, launched in 2007, involved collaboration from 115 contributors, including researchers, healthcare professionals, and regulatory bodies. The checklist, consisting of 33 items and a diagram, aims to ensure that trial protocols include essential elements such as study design, population, interventions, and trial registration. The SPIRIT Statement and E&E paper are intended to be used together to help draft trial protocols, ensuring transparency and completeness. The paper also highlights the importance of including information on funding sources, sponsor roles, and trial design, as well as the need for clear descriptions of interventions and outcomes. The SPIRIT Statement emphasizes the importance of transparency in trial protocols to ensure that all stakeholders, including regulatory agencies, ethics committees, and funders, can assess the trial's conduct and reporting. The paper also provides examples of how to describe trial settings, eligibility criteria, and intervention details, as well as the importance of including information on trial registration and data management. Overall, the SPIRIT 2013 Statement and E&E paper aim to improve the quality and completeness of clinical trial protocols, ensuring that they are transparent, comprehensive, and useful for all stakeholders involved in the trial.The SPIRIT 2013 Statement provides guidance for clinical trial protocols, aiming to improve their completeness and quality. It includes a checklist of recommended items and an accompanying Explanation and Elaboration paper that provides detailed descriptions, rationale, and examples for each checklist item. The SPIRIT Initiative, launched in 2007, involved collaboration from 115 contributors, including researchers, healthcare professionals, and regulatory bodies. The checklist, consisting of 33 items and a diagram, aims to ensure that trial protocols include essential elements such as study design, population, interventions, and trial registration. The SPIRIT Statement and E&E paper are intended to be used together to help draft trial protocols, ensuring transparency and completeness. The paper also highlights the importance of including information on funding sources, sponsor roles, and trial design, as well as the need for clear descriptions of interventions and outcomes. The SPIRIT Statement emphasizes the importance of transparency in trial protocols to ensure that all stakeholders, including regulatory agencies, ethics committees, and funders, can assess the trial's conduct and reporting. The paper also provides examples of how to describe trial settings, eligibility criteria, and intervention details, as well as the importance of including information on trial registration and data management. Overall, the SPIRIT 2013 Statement and E&E paper aim to improve the quality and completeness of clinical trial protocols, ensuring that they are transparent, comprehensive, and useful for all stakeholders involved in the trial.