Clinical trials are conducted on children for various purposes, but most often, they are designed to improve treatment methods and provide advances in medicine and health care services. Parents must give consent for children to participate in these trials. But do parents always understand the nature of the trials?
This question was the impetus for a new study led by Kerry Woolfall of the Department of Psychological Sciences at the University of Liverpool in the United Kingdom. Most pediatric clinical trials are explained to parents, but there appears to be a gap between consent in informed consent. In other words, some evidence suggests that parents who enroll their children in clinical trials often misunderstand what the trial consists of.
Some reasons for these misunderstandings are the trust the parents have in the recruiting doctor, their own motivation for enrolling their child, and their own beliefs about the trial. Therefore, it is unclear whether or not parents’ conceptions of the clinical trials their children are participating in match the expectations and conceptions held by the researchers.
To get a better idea of what misconceptions parents may have and why, Woolfall assessed 82 induction interviews between parents and doctors. The parents were asked what factors motivated them to enroll their children. The top reasons and concerns were access to care and medication, benefits to the general population, clinical benefits, the safety of their child, and the feasibility of trial participation. Woolfall found that randomization was of concern, but greatly misunderstood by the parents. Additionally, the access to medicine and overall goal of the research was also misinterpreted by many of the parents.
Woolfall also discovered that although many of the parents had concerns, they did not raise them when they were being interviewed for trial participation. This is particularly disturbing, as these concerns were important to the decision making process for many of the parents. Woolfall believes these findings show that there is a discrepancy between a parent’s understanding and a clinician’s perception of that understanding when enrolling children in clinical studies.
Woolfall added, “Those involved in the recruitment of children to clinical trials need to be aware of parents’ priorities and the sorts of misunderstandings that can arise with parents.” Information that is geared toward addressing parental concern and informed decision making could close this gap in understanding and result in more effective and targeted recruitment for pediatric clinical trials.
Woolfall, K., Shilling, V., Hickey, H., Smyth, R.L., Sowden, E., et al. (2013). Parents’ agendas in pediatric clinical trial recruitment are different from researchers’ and often remain unvoiced: A qualitative study. PLoS ONE 8(7): e67352. doi:10.1371/journal.pone.0067352
© Copyright 2013 GoodTherapy.org. All rights reserved.
The preceding article was solely written by the author named above. Any views and opinions expressed are not necessarily shared by GoodTherapy.org. Questions or concerns about the preceding article can be directed to the author or posted as a comment below.