SPIRIT 2013 statement: defining standard protocol items for clinical trials.
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The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
Published Version (Please cite this version)10.7326/0003-4819-158-3-201302050-00583
Publication InfoAltman, DG; Berlin, JA; Chan, An-Wen; Dickersin, K; Doré, CJ; Gøtzsche, PC; ... Tetzlaff, JM (2013). SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 158(3). pp. 200-207. 10.7326/0003-4819-158-3-201302050-00583. Retrieved from http://hdl.handle.net/10161/11031.
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Professor of Biostatistics & Bioinformatics
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. In addition his role of full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, Frank is also Managing Partner of HunterRock