Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis

• Marcin Waligora,

  Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Writing – original draft, Writing – review & editing

  Affiliation Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland

  http://orcid.org/0000-0002-1553-1416

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• Malgorzata M. Bala ,

  Roles Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing

  * E-mail: malgorzata.1.bala@uj.edu.pl (MMB); jonathan.kimmelman@mcgill.ca (JK)

  Affiliation Department of Hygiene and Dietetics, Chair of Epidemiology and Preventive Medicine, Jagiellonian University Medical College, Kraków, Poland

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• Magdalena Koperny,

  Roles Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing

  Affiliations Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland, Department of Public Health and Health Promotion, Regional Sanitary-Epidemiological Station in Kraków, Poland

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• Mateusz T. Wasylewski,

  Roles Data curation, Formal analysis, Investigation, Writing – review & editing

  Affiliation Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland

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• Karolina Strzebonska,

  Roles Data curation, Formal analysis, Investigation, Visualization, Writing – review & editing

  Affiliation Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland

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• Rafał R. Jaeschke,

  Roles Investigation, Writing – review & editing

  Affiliation Section of Affective Disorders, Department of Psychiatry, Jagiellonian University Medical College, Kraków, Poland

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• Agnieszka Wozniak,

  Roles Investigation, Writing – review & editing

  Affiliation Agency for Health Technology Assessment and Tariff System, Warsaw, Poland

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• Jan Piasecki,

  Roles Investigation, Writing – review & editing

  Affiliation Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland

  http://orcid.org/0000-0003-1298-736X

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• Agnieszka Sliwka,

  Roles Investigation, Writing – review & editing

  Affiliations Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland, Department of Rehabilitation in Internal Diseases, Jagiellonian University Medical College, Kraków, Poland

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• Jerzy W. Mitus,

  Roles Investigation, Writing – review & editing

  Affiliations Department of Surgical Oncology, Maria Skłodowska-Curie Memorial Cancer Centre and Institute of Oncology, Kraków, Poland, Department of Anatomy, Jagiellonian University Medical College, Kraków, Poland

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• Maciej Polak,

  Roles Formal analysis, Methodology, Software, Writing – review & editing

  Affiliations Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Kraków, Poland, Chair of Epidemiology and Population Studies, Jagiellonian University Medical College, Kraków, Poland

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• Dominika Nowis,

  Roles Validation, Writing – review & editing

  Affiliations Department of Immunology, Medical University of Warsaw, Warsaw, Poland, Genomic Medicine, Medical University of Warsaw, Warsaw, Poland, Laboratory of Experimental Medicine, Centre of New Technologies, University of Warsaw, Warsaw, Poland

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• Dean Fergusson,

  Roles Formal analysis, Methodology, Writing – review & editing

  Affiliation Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada

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• Jonathan Kimmelman

  Roles Conceptualization, Formal analysis, Methodology, Supervision, Validation, Writing – original draft, Writing – review & editing

  * E-mail: malgorzata.1.bala@uj.edu.pl (MMB); jonathan.kimmelman@mcgill.ca (JK)

  Affiliation Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montreal, Canada

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