1. Enrolment in paediatric oncology early-phase clinical trials: The health-care professionals' perspective.
- Author
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Robertson EG, Mitchell R, Wakefield CE, Lewis P, Cousens N, Marshall GM, Russell SJ, Ziegler DS, Anazodo AC, Trahair TN, Barbaric D, Cohn RJ, Alvaro F, and O'Brien TA
- Subjects
- Adolescent, Adult, Australia, Child, Child, Preschool, Clinical Trials, Phase III as Topic, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, New Zealand, Parent-Child Relations, Pediatrics organization & administration, Attitude of Health Personnel, Decision Making, Shared, Health Personnel statistics & numerical data, Medical Oncology organization & administration, Patient Selection, Surveys and Questionnaires
- Abstract
Aim: Approximately 20-30% of children/adolescents with cancer will not respond to standard therapies. These children are usually offered experimental treatment in the form of an early-phase clinical trial. We examined the perspectives of health-care professionals (HCPs) regarding obtaining informed consent for early-phase trials in paediatric oncology., Methods: We collected survey data from 87 HCPs working in paediatric cancer centres across Australia and New Zealand., Results: HCPs were, on average, 44 years old (range = 25-74), with 15.8 years' experience in paediatric oncology (range = 1-40). Few HCPs (17.4%) received training for early-phase trial consent; however, most were willing to attend training (77.9%). HCPs (61.6%) reported that they informed families about early-phase trials without any attempt to influence their decision. However, 23.3% of HCPs reported that they informed families that their child would benefit. HCPs' main obstacle in obtaining consent was their perception of parents' eagerness to 'try anything' (52.3%). HCPs perceived that many parents misunderstood key clinical trials concepts, with 25.2% of HCPs believing that not being given clear information influenced parents' decisions. Physicians were more likely than social workers/nurses to inform families that other children will benefit from enrolment in the study. Social workers/nurses appeared to rate the chance of benefits for the patient higher than physicians., Conclusions: HCPs may experience difficulty conducting early-phase trial consultations and obtaining valid informed consent. Our study highlights the need for formal training for HCPs and additional patient education tools., (© 2018 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)
- Published
- 2019
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