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August 22, 2019

An Important Gap in Informed Consent Documents for Oncology Clinical Trials: Lack of Quantitative Details About Expected Treatment Outcomes

Author Affiliations
  • 1Department of Oncology, Karmanos Cancer Institute, Wayne State University of Medicine, Detroit, Michigan
JAMA Oncol. Published online August 22, 2019. doi:10.1001/jamaoncol.2019.3146

Written informed consent must be obtained in addition to the discussions that physicians have with patients considering participation in clinical trials. Implicit in this requirement is the assumption that these dialogues with the caregivers are insufficient, requiring supplementation by written documents to reinforce what had been presented and/or to provide details that may not have been mentioned. The consents should be written in lay language with clear explanations of scientific and medical terms.1 Over the years, consent forms have become longer and more detailed and there is an extensive literature about how much information is actually retained by the patient after reading about Health Insurance Portability and Accountability regulations, handling of biologic specimens, long lists of potential adverse effects, the nature of randomization, etc.2 There are concerns that this litany of details distracts attention from the most critical features, including the aims of the study and the extra requirements and inconveniences compared with standard care.

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