How Informed Are Parents of Children Enrolled in Clinical Trials?

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.

Reference:
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

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  • Amanda McDaniel

    Amanda McDaniel

    July 26th, 2013 at 4:08 AM

    If I am a parent enrolling my child in a clinical trial, believe me, I am going to want to know everything that there is to know before I let her do it. I am so surprised when I read that there are many parents who do not raise concerns, I guess because they are intimidated by the doctors or the medical setting? I guess I understand those feelings, but I would want to know that everyone involved has educated me and that I have educated myself about the study and the dnagers and complications that could arise as a result.

  • clint

    clint

    July 27th, 2013 at 4:46 AM

    These are clinical trials that many families are putting all of their faith and trust in. They believe that this could be the one thing that could save their child and so they are willing to go with it full steam ahead often without all of the information, or most likely going ahead with it believing about it what they want to believe. I think that families who are placed in these situations will often delude themselves about what the outcomes will be, not because they haven’t been given the information but because for many of them this is their last chance to see improveemnt or a cure for a family member. They have to try as I think any of us would have to try, and I don’t think that there is any fault here, other than maybe we gloss over the potential side effects when are looking for something that could be a miracle.

  • Kyla

    Kyla

    July 29th, 2013 at 4:41 AM

    I think that with real people and the medical community there is always this disconnect, and even more so between those doctors who lack that bedside manner and are just looking at things from a scientific and research point of view. They of course care about the families’ feelings, but they are more concerned with how the drugs and the program is going to work, and maybe this is where there is some communication breakdown.

  • Matt M

    Matt M

    May 6th, 2015 at 9:46 AM

    It is important to keep parents informed through every step of the process when their children are involved in clinical research. I agree that when dealing with children and their parents, a more personal approach should be taken. These volunteers are not simply statistics, they are people who will respond and react to how they are treated at all times throughout clinical research. They are volunteering their time to contribute in clinical research, and as such, should be accommodated and treated with care and respect. It is important to obtain results and analyze potential new treatments, but this need for results should not eliminate the humanity that is involved in treating people for their conditions, especially when it comes to children.

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