(ChemotherapyAdvisor) – Parents of children who participate in phase 1 clinical trials may not understand the purpose of the research because physician-parent communication is lacking during informed consent conferences, a study in the Journal of Clinical Oncology online October 15 reported.
Between June 2008 and May 2011, Eric D. Kodish, MD, of the Center for Ethics, Humanities, and Spiritual Care, Cleveland Clinic, Cleveland, OH, and colleagues directly observed 85 informed consent conferences for phase 1 research in the multisite Informed Consent in Pediatric Phase I Cancer Trials study.
“If parents are to make a truly informed decision about their child’s participation in phase I research, they must understand the scientific purpose of the study because individual risks associated with study participation may well outweigh benefits,” they wrote. “However, research on pediatric clinical trials, like that in adult oncology, has demonstrated deficiencies in parental understanding of research-related topics and prognosis.”
For this study, “the scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation.” The investigators “determined the frequency with which physicians explained these and other phase I-related concepts during the informed consent conference,” Dr. Kodish noted. To determine whether parents understood, they analyzed the interviews.
Of the 85 informed consent conferences, the child was present at 83.
“Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding,” they found. The scientific purpose was more likely to be understood if the parents were of higher socioeconomic status and racial majority status.
Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered, delineated in 85% of the conferences, and explanation of the dose cohorts, explained in 43%. During the informed consent conferences, physicians explained drug safety in 23%, dose finding in 52%, and dose escalation in 53%.
“In sum, children with refractory cancer who are recruited for phase I trials represent one of the most vulnerable populations of human study participants. Although findings show that the children are almost always present at the informed consent conferences, substantial barriers and ethical challenges to high-quality informed consent remain,” they concluded.