Parents need more help understanding phase 1 trials

A study published this week in the Journal of Clinical Oncology suggests that physicians need to work on their presentation of phase 1 trials to parents of children with cancer.

Dr. Eric Kodish and colleagues recorded 85 consent discussions at children’s hospitals across the US that conduct phase 1 pediatric oncology trials. Parents were interviewed about a week after the initial consent discussion; at that time point, only 32% demonstrated “substantial understanding of the scientific purpose of Phase 1 cancer trials; 35% demonstrated little or no understanding.”

The study also examined how well physicians explained important early-phase concepts such as safety testing, dose finding and dose escalation. The researchers found that complete information wasn’t provided on a consistent basis:

Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs [informed consent conferences]) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs.

Let’s flip those numbers…

  • Purpose of the trial not explained – 15%
  • Dose cohorts not explained – 57%
  • Safety testing not explained – 77%
  • Dose finding not explained – 48%
  • Dose escalation not explained – 47%

Presumably – the abstract doesn’t mention this, and the full article is behind the journal’s pay wall – the approved consent documents for these studies included all required elements and did not overstate the potential for direct benefit. An analysis published in 2002 concluded that consent forms were “unlikely to be the primary source of misunderstanding by subjects in phase 1 oncology trials”.

Low health literacy is almost certainly a contributing factor. In this study, education was strongly associated with a higher level of scientific understanding. Information overload and the therapeutic misconception are also in play when parents are asked to sign pages and pages of consent forms soon after learning a child’s diagnosis. This study illustrates the importance of physician guidance during the decision making process. One positive finding was that children were included in nearly all of the consent discussions.

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