International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR.
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| Title: | International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR. |
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| Authors: | Alger E; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom., Aiyegbusi OL; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom.; NIHR Birmingham Biomedical Research Centre (BRC), University of Birmingham, Birmingham, United Kingdom., Dueck AC; Mayo Clinic, Scottsdale, AZ., Minchom A; Royal Marsden Hospital/Institute of Cancer Research, London, United Kingdom., Pe M; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Peipert JD; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, United Kingdom., Snyder C; Johns Hopkins School of Medicine, Baltimore, MD., Symeonides SN; Edinburgh Cancer Centre, NHS Lothian, Edinburgh, United Kingdom.; Edinburgh Experimental Cancer Medicine Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, United Kingdom., Wilson R; Cancer Research Advocates Forum UK, Stevenage, United Kingdom., Basch E; The University of North Carolina at Chapel Hill, Chapel Hill, NC., Qiao Y; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom., Bates SE; Columbia University Irving Medical Center, New York, NY., Bulbeck H; Brainstrust-The Brain Cancer People, Cowes, United Kingdom., Dean L; Cancer Research Advocates Forum UK, Stevenage, United Kingdom., Di Maio M; Department of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Turin, Italy., Hansen AR; Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia., Kholmanskikh O; Federal Agency for Medicines and Health Products, Brussel, Belgium., Kobayashi K; Small Woods Biopharma Consulting, LLC, San Diego, CA., Landers D; Early Clinical Development, Dukes Street Bio Ltd, London, United Kingdom., Le Tourneau C; Department of Drug Development and Innovation (D3i), Institut Curie, Paris-Saclay University, Paris, France., Lee JJ; University of Texas MD Anderson Cancer Center, Houston, TX., Ma BBY; State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Phase 1 Clinical Trial Centre, Sir YK Pao Centre for Cancer, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong, China., Marshall LV; Children & Young People's Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom.; Division of Clinical Studies, The Institute of Cancer Research, London, United Kingdom., Patel S; Genentech, San Francisco, CA., Petrie J; Canadian Cancer Trials Group (CCTG), Kingston, ON, Canada., Pond GR; McMaster University, Hamilton, ON, Canada., Prior K; Cancer Research UK, London, United Kingdom., Rantell KR; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom., Reeve JF; Cancer Research Advocates Forum UK, Stevenage, United Kingdom., Solovyeva O; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom., Wages NA; Department of Biostatistics, Virginia Commonwealth University, Richmond, VA.; Massey Comprehensive Cancer Center, Richmond, VA., Weber HA; Pfizer AG, Zug, Switzerland., Calvert MJ; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom.; NIHR Birmingham Biomedical Research Centre (BRC), University of Birmingham, Birmingham, United Kingdom.; Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, United Kingdom.; NIHR Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, United Kingdom.; University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom., Yap C; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom. |
| Source: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2026 Mar 10; Vol. 44 (8), pp. 709-719. Date of Electronic Publication: 2026 Jan 23. |
| Publication Type: | Consensus Statement; Journal Article; Research Support, N.I.H., Extramural |
| Journal Info: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 41576310 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Alger+E%22">Alger E</searchLink>; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Aiyegbusi+OL%22">Aiyegbusi OL</searchLink>; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom.; NIHR Birmingham Biomedical Research Centre (BRC), University of Birmingham, Birmingham, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Dueck+AC%22">Dueck AC</searchLink>; Mayo Clinic, Scottsdale, AZ.<br /><searchLink fieldCode="AU" term="%22Minchom+A%22">Minchom A</searchLink>; Royal Marsden Hospital/Institute of Cancer Research, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Pe+M%22">Pe M</searchLink>; European Organisation for Research and Treatment of Cancer, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Peipert+JD%22">Peipert JD</searchLink>; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Snyder+C%22">Snyder C</searchLink>; Johns Hopkins School of Medicine, Baltimore, MD.<br /><searchLink fieldCode="AU" term="%22Symeonides+SN%22">Symeonides SN</searchLink>; Edinburgh Cancer Centre, NHS Lothian, Edinburgh, United Kingdom.; Edinburgh Experimental Cancer Medicine Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Wilson+R%22">Wilson R</searchLink>; Cancer Research Advocates Forum UK, Stevenage, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Basch+E%22">Basch E</searchLink>; The University of North Carolina at Chapel Hill, Chapel Hill, NC.<br /><searchLink fieldCode="AU" term="%22Qiao+Y%22">Qiao Y</searchLink>; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Bates+SE%22">Bates SE</searchLink>; Columbia University Irving Medical Center, New York, NY.<br /><searchLink fieldCode="AU" term="%22Bulbeck+H%22">Bulbeck H</searchLink>; Brainstrust-The Brain Cancer People, Cowes, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Dean+L%22">Dean L</searchLink>; Cancer Research Advocates Forum UK, Stevenage, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Di+Maio+M%22">Di Maio M</searchLink>; Department of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Turin, Italy.<br /><searchLink fieldCode="AU" term="%22Hansen+AR%22">Hansen AR</searchLink>; Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.<br /><searchLink fieldCode="AU" term="%22Kholmanskikh+O%22">Kholmanskikh O</searchLink>; Federal Agency for Medicines and Health Products, Brussel, Belgium.<br /><searchLink fieldCode="AU" term="%22Kobayashi+K%22">Kobayashi K</searchLink>; Small Woods Biopharma Consulting, LLC, San Diego, CA.<br /><searchLink fieldCode="AU" term="%22Landers+D%22">Landers D</searchLink>; Early Clinical Development, Dukes Street Bio Ltd, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Le+Tourneau+C%22">Le Tourneau C</searchLink>; Department of Drug Development and Innovation (D3i), Institut Curie, Paris-Saclay University, Paris, France.<br /><searchLink fieldCode="AU" term="%22Lee+JJ%22">Lee JJ</searchLink>; University of Texas MD Anderson Cancer Center, Houston, TX.<br /><searchLink fieldCode="AU" term="%22Ma+BBY%22">Ma BBY</searchLink>; State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Phase 1 Clinical Trial Centre, Sir YK Pao Centre for Cancer, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong, China.<br /><searchLink fieldCode="AU" term="%22Marshall+LV%22">Marshall LV</searchLink>; Children & Young People's Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom.; Division of Clinical Studies, The Institute of Cancer Research, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Patel+S%22">Patel S</searchLink>; Genentech, San Francisco, CA.<br /><searchLink fieldCode="AU" term="%22Petrie+J%22">Petrie J</searchLink>; Canadian Cancer Trials Group (CCTG), Kingston, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Pond+GR%22">Pond GR</searchLink>; McMaster University, Hamilton, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Prior+K%22">Prior K</searchLink>; Cancer Research UK, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Rantell+KR%22">Rantell KR</searchLink>; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Reeve+JF%22">Reeve JF</searchLink>; Cancer Research Advocates Forum UK, Stevenage, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Solovyeva+O%22">Solovyeva O</searchLink>; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Wages+NA%22">Wages NA</searchLink>; Department of Biostatistics, Virginia Commonwealth University, Richmond, VA.; Massey Comprehensive Cancer Center, Richmond, VA.<br /><searchLink fieldCode="AU" term="%22Weber+HA%22">Weber HA</searchLink>; Pfizer AG, Zug, Switzerland.<br /><searchLink fieldCode="AU" term="%22Calvert+MJ%22">Calvert MJ</searchLink>; Centre for Patient-Reported Outcomes, University of Birmingham, Birmingham, United Kingdom.; Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom.; NIHR Birmingham Biomedical Research Centre (BRC), University of Birmingham, Birmingham, United Kingdom.; Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, United Kingdom.; NIHR Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, United Kingdom.; University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Yap+C%22">Yap C</searchLink>; Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%228309333%22">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</searchLink> [J Clin Oncol] 2026 Mar 10; Vol. 44 (8), pp. 709-719. <i>Date of Electronic Publication: </i>2026 Jan 23. – Name: TypePub Label: Publication Type Group: TypPub Data: Consensus Statement; Journal Article; Research Support, N.I.H., Extramural – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Society+of+Clinical+Oncology%22">American Society of Clinical Oncology </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>8309333 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1527-7755 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%220732183X%22">0732183X </searchLink><i>NLM ISO Abbreviation: </i>J Clin Oncol <i>Subsets: </i>MEDLINE |
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