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Research Letter
December 6, 2018

Assessment of Frequency and Reporting of Changes in Cancer Trial Design After Initiation of Patient Accrual

Author Affiliations
  • 1Division of Medical Oncology & Hematology, Department of Medicine, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  • 2Department of Internal Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • 3Oncology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
  • 4Department of Oncology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • 5Research Unit, Translational Oncology Laboratory, Regional Center for Biomedical Research (CRIB), Albacete University Hospital, Albacete, Spain
  • 6Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Castilla–La Mancha University, Albacete, Spain
  • 7Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia
  • 8Department of Medicine, University of Toronto, Toronto, Ontario, Canada
JAMA Oncol. Published online December 6, 2018. doi:10.1001/jamaoncol.2018.5877

Changes in trial design after the onset of patient accrual can affect the scientific basis of evidence-based medicine and should be reported and justified.1 Data on the prevalence of these changes in oncology drug development are scarce. We aimed to quantify these changes in trials that supported cancer drug approval by the US Food and Drug Administration (FDA) and to explore the associations of such changes with study characteristics and drug-approval processes.

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