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SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials.

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Title: SPIRIT 2025 Statement: Updated Guideline for Protocols of Randomized Trials.
Authors: Chan AW; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada., Boutron I; Centre for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Paris, France.; Centre d'Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France., Hopewell S; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom., Moher D; Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada., Schulz KF; Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill., Collins GS; United Kingdom EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom., Tunn R; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom., Aggarwal R; Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India., Berkwits M; Office of Science Dissemination, Centers for Disease Control and Prevention, Atlanta, Georgia., Berlin JA; Center for Pharmacoepidemiology and Treatment Science, Department of Biostatistics and Epidemiology, School of Public Health, Rutgers University, New Brunswick, New Jersey.; JAMA Network Open , Chicago, Illinois., Bhandari N; Centre for Health Research and Development, Society for Applied Studies, New Delhi, India., Butcher NJ; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada., Campbell MK; Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom., Chidebe RCW; Project PINK BLUE - Health & Psychological Trust Centre, Utako, Abuja, Nigeria.; Department of Sociology and Gerontology, Miami University, Ohio., Elbourne DR; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom., Farmer AJ; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom., Fergusson DA; Ottawa Hospital Research Institute, Ottawa, Ontario, Canada., Golub RM; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois., Goodman SN; Department of Epidemiology and Population Health, Stanford University, Palo Alto, California., Hoffmann TC; Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia., Ioannidis JPA; Department of Medicine, Stanford University, Stanford, California.; Department of Epidemiology and Population Health, Stanford University, Stanford, California.; Department of Biomedical Data Science, Stanford University, Stanford, California.; Department of Statistics, Stanford University, Stanford, California.; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California., Kahan BC; MRC Clinical Trials Unit, University College London, London, United Kingdom., Knowles RL; UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom., Lamb SE; NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom., Lewis S; Edinburgh Clinical Trials Unit, Usher Institute-University of Edinburgh, Edinburgh BioQuarter, Edinburgh, United Kingdom., Loder E; The BMJ , BMA House, London, United Kingdom.; Harvard Medical School, Boston, Massachusetts., Offringa M; Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada., Ravaud P; Centre de Recherche Epidémiologie et Statistiques, Université Paris Cité, Inserm, INRAE, Paris, France., Richards DP; Clinical Trials Ontario, MaRS Centre, Toronto, Ontario, Canada., Rockhold FW; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina., Schriger DL; Department of Emergency Medicine, University of California, Los Angeles., Siegfried NL; South African Medical Research Council, Cape Town, South Africa., Staniszewska S; Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom., Taylor RS; MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom., Thabane L; Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.; St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada., Torgerson DJ; York Trials Unit, Department of Health Sciences, University of York, York, United Kingdom., Vohra S; Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada., White IR; MRC Clinical Trials Unit, University College London, London, United Kingdom., Hróbjartsson A; Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Open Patient Data Explorative Network, Odense University Hospital, Odense, Denmark.
Source: JAMA [JAMA] 2025 Aug 05; Vol. 334 (5), pp. 435-443.
Publication Type: Journal Article; Practice Guideline; Research Support, Non-U.S. Gov't
Journal Info: Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE
Database: MEDLINE Ultimate
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Description
ISSN:1538-3598
DOI:10.1001/jama.2025.4486