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Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Yap, Christina; Solovyeva, Olga; de Bono, Johann; Rekowski, Jan; Patel, Dhrusti; Jaki, Thomas; Mander, Adrian; Evans, Thomas R Jeffry; Peck, Richard; Hayward, Kathryn S; Hopewell, Sally; Ursino, Moreno; Rantell, Khadija Rerhou; Calvert, Melanie; Lee, Shing; Kightley, Andrew; Ashby, Deborah; Chan, An-Wen; Garrett-Mayer, Elizabeth; Isaacs, John D; Golub, Robert; Kholmanskikh, Olga; Richards, Dawn; Boix, Oliver; Matcham, James; Seymour, Lesley; Ivy, S Percy; Marshall, Lynley V; Hommais, Antoine; Liu, Rong; Tanaka, Yoshiya; Berlin, Jordan; Espinasse, Aude; Dimairo, Munyaradzi; Weir, Christopher J.
Affiliation
  • Yap C; Institute of Cancer Research, London SM2 5NG, UK.
  • Solovyeva O; Institute of Cancer Research, London SM2 5NG, UK.
  • de Bono J; Institute of Cancer Research, London SM2 5NG, UK.
  • Rekowski J; Royal Marsden NHS Foundation Trust, London, UK.
  • Patel D; Institute of Cancer Research, London SM2 5NG, UK.
  • Jaki T; Institute of Cancer Research, London SM2 5NG, UK.
  • Mander A; MRC Biostatistics Unit, Cambridge University, Cambridge, UK.
  • Evans TRJ; Computational Statistics Group, University of Regensburg, Regensburg, Germany.
  • Peck R; Centre For Trials Research, Cardiff University, Heath Park, Cardiff, UK.
  • Hayward KS; Institute of Cancer Sciences, CR-UK Beatson Institute, University of Glasgow, Glasgow, UK.
  • Hopewell S; Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
  • Ursino M; Hoffmann-La Roche, Basel, Switzerland.
  • Rantell KR; Departments of Physiotherapy, and Medicine (Royal Melbourne Hospital), University of Melbourne, VIC, Australia.
  • Calvert M; Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, VIC, Australia.
  • Lee S; Oxford Clinical Research Unit, NDORMS, University of Oxford, Oxford, UK.
  • Kightley A; ReCAP/F CRIN, INSERM, Paris, France.
  • Ashby D; Unit of Clinical Epidemiology, CHU Robert Debré, APHP, URC, INSERM CIC-EC 1426, Reims, France.
  • Chan AW; INSERM Centre de Recherche des Cordeliers, Sorbonne University, Paris Cité University, Paris, France.
  • Garrett-Mayer E; Health data and model driven approaches for Knowledge Acquisition team, Centre Inria, Paris, France.
  • Isaacs JD; Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Golub R; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
  • Kholmanskikh O; Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
  • Richards D; National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK.
  • Boix O; NIHR Research Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham, Edgbaston, Birmingham, UK.
  • Matcham J; NIHR Birmingham Biomedical Research Centre, Institute of Translational Medicine, University Hospital NHS Foundation Trust, Birmingham, UK.
  • Seymour L; Columbia University Mailman School of Public Health, New York, NY, USA.
  • Ivy SP; Lichfield, UK.
  • Marshall LV; School of Public Health, Imperial College London, London, UK.
  • Hommais A; Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
  • Liu R; Center for Research and Analytics, American Society of Clinical Oncology, Alexandria, VA, USA.
  • Tanaka Y; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
  • Berlin J; Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
  • Espinasse A; Department of Medicine, Northwestern University Feinberg School of Medicine, 633 Clark Street, Evanston, IL, USA.
  • Dimairo M; Federal Agency for Medicines and Health Products, Brussels, Belgium.
  • Weir CJ; European Medicines Agency, Amsterdam, Netherlands.
BMJ ; 383: e076387, 2023 10 20.
Article in En | MEDLINE | ID: mdl-37863501

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Checklist Limits: Humans Language: En Journal: BMJ Journal subject: MEDICINA Year: 2023 Document type: Article Affiliation country: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Checklist Limits: Humans Language: En Journal: BMJ Journal subject: MEDICINA Year: 2023 Document type: Article Affiliation country: United kingdom
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