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SPIRIT 2025 statement: Updated guideline for protocols of randomised trials
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An-Wen Chan ,
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing
* E-mail: anwen.chan@utoronto.ca
Affiliation Department of Medicine, Women’s College Research Institute, University of Toronto, Toronto, Ontario, Canada
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Isabelle Boutron,
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing
Affiliations Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France, Centre d’Epidémiologie Clinique, Hôpital Hôtel Dieu, AP-HP, Paris, France
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Sally Hopewell,
Roles Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing
Affiliation Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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David Moher,
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing
Affiliation Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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Kenneth F. Schulz,
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing
Affiliation Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
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Gary S. Collins,
Roles Funding acquisition, Writing – original draft
Affiliation UK EQUATOR Centre, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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Ruth Tunn,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom
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Rakesh Aggarwal,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
⨯ - Michael Berkwits,
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Jesse A. Berlin,
Roles Data curation, Funding acquisition, Investigation, Writing – review & editing
Affiliations Department of Biostatistics and Epidemiology, School of Public Health, Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey, United States of America, JAMA Network Open, Chicago, Illinois, United States of America
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Nita Bhandari,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Centre for Health Research and Development, Society for Applied Studies, New Delhi, India
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Nancy J. Butcher,
Roles Data curation, Investigation, Writing – review & editing
Affiliations Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
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Marion K. Campbell,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom
⨯ - Runcie C. W. Chidebe,
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Diana R. Elbourne,
Roles Conceptualization, Data curation, Investigation, Writing – review & editing
Affiliation Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom
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Andrew J. Farmer,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
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Dean A. Fergusson,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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Robert M. Golub,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America
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Steven N. Goodman,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Department of Epidemiology and Population Health, Stanford University, Palo Alto, California, United States of America
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Tammy C. Hoffmann,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Institute for Evidence-Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Queensland, Australia
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John P. A. Ioannidis,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, and Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, United States of America
⨯ - Brennan C. Kahan,
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Rachel L. Knowles,
Roles Data curation, Investigation, Writing – review & editing
Affiliation University College London, UCL Great Ormond Street Institute of Child Health, London, United Kingdom
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Sarah E. Lamb,
Roles Data curation, Investigation, Writing – review & editing
Affiliation NIHR Exeter Biomedical Research Centre, Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom
⨯ - Steff Lewis,
- Elizabeth Loder,
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Martin Offringa,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Child Health Evaluation Services, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
⨯ - Philippe Ravaud,
- Dawn P. Richards,
- Frank W. Rockhold,
- David L. Schriger,
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Nandi L. Siegfried,
Roles Data curation, Investigation, Writing – review & editing
Affiliation South African Medical Research Council, Cape Town, South Africa
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Sophie Staniszewska,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Warwick Applied Health, Warwick Medical School, University of Warwick, Coventry, United Kingdom
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Rod S. Taylor,
Roles Data curation, Investigation, Writing – review & editing
Affiliation MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
⨯ - Lehana Thabane,
- David J. Torgerson,
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Sunita Vohra,
Roles Data curation, Investigation, Writing – review & editing
Affiliation Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
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Ian R. White,
Roles Data curation, Investigation, Writing – review & editing
Affiliation MRC Clinical Trials Unit at University College London, London, United Kingdom
⨯ - [ ... ],
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Asbjørn Hróbjartsson
Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Writing – original draft, Writing – review & editing
Affiliations 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
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https://orcid.org/0000-0002-4498-3382
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials
- An-Wen Chan,
- Isabelle Boutron,
- Sally Hopewell,
- David Moher,
- Kenneth F. Schulz,
- Gary S. Collins,
- Ruth Tunn,
- Rakesh Aggarwal,
- Michael Berkwits,
- Jesse A. Berlin
- Published: April 28, 2025
- https://doi.org/10.1371/journal.pmed.1004589