Educating parents about clinical trials with children
Follow-up burden is major issue
Community education and informed consent about an investigational treatment will be a more intense process when it involves parents of seriously ill children.
Clinical research staff should keep in mind that a family's quality of life is very important when they discuss a treatment the sick child could obtain through research, says Jean Connor, DNSc, RN, CPNP, co-director of the cardiology clinical research and regulatory group at Children's Hospital Boston in Boston, MA. Connor also is a nurse scientist for the cardiovascular program and a faculty member of the measurement committee for the program of patient safety and quality.
"In my world with children with cardiac problems, there are medical therapies and different devices that are experimental and can be obtained through enrolling in these studies," Connor explains. "You have to weigh as part of that conversation with parents the quality of life of the family."
Research investigators and coordinators will ask the families what their expectations are for the benefit of the study, Connor says.
"And what is the burden of the follow-up that is required as part of the study?" she adds.
The follow-up often is quite an onerous burden.
The Food and Drug Administration (FDA) requires that these investigational treatments assess safety and efficacy during a five-year time frame, Connor says.
"Now it's extended to five years past when the investigational treatment occurred, and that's a burden on the family," Connor says. "They have to commit to follow-ups."
So discussions with families in community meetings or informed consent, one-on-one meetings, should answer these questions:
- How frequently will research participants need to make visits?
- What kind of tests will be done at visits?
- Do the tests involve risks and what kind?
- How long will the follow-up period last?
"Families have busy lives, and often we're dealing with families where there's more than one child," Connor says. "So you have to cover not only the risks and benefits of the actual device, but also the burdens of getting that device."
For all of these reasons, the informed consent process is a gradual and layered process.
When dealing with parents who have a sick child, researchers should keep in mind that the conversation will be fragile and vulnerable from their perspective, Connor notes.
"We usually have this discussion in stages," she explains. "We do not just tell the family about the study and in the same conversation ask for their consent."
Instead, researchers give the families a period of time to process and synthesize the information, having several conversations about the study before actually enrolling the children.
"If it's an emergency situation then that won't happen, but more times than not we give families extra time to decide," Connor says.
Clinical research investigators and coordinators also are sensitive to the vulnerability of families who come to the Children's Hospital. This vulnerability often means that parents will believe that if a physician at the hospital is discussing a clinical trial with them then it means their child's study participation will definitely benefit the child medically.
"What commonly happens is families will come to a place like the Children's Hospital, and it's a specialized place," Connor says. "And they feel like they're talking to the best person in the field or world, and they'll say, 'What ever you think is best, doctor,'" Connor says. "We really don't accept that as informed consent."
For example, suppose a family came to the hospital from out-of-state and they've been meeting with physicians and others to discuss their child's devastating illness, Connor says.
They might be overwhelmed and tired by the time they hear about the clinical trial. Out of fatigue and trust, they will volunteer to sign the informed consent form at that moment.
"But I say, 'No we need to talk about this some more,'" Connor says. "We try to have them come back for another visit after they've had time to synthesize the information."
So Connor will tell them, "What we'll do is come back tomorrow morning, and we'll go over this again. I'm sure you'll have questions, and we'll address those questions."
Then, the next morning, Connor will ask the parents some questions to challenge them to make sure they understand the informed consent information.
"I want to make sure they have the important concepts correct," Connor says. "What should their expectations be about this therapy?"
Families usually are relieved when told they need to take more time to think about the decision, she observes.
"They want to make your life easier and ask, 'Would it help if we signed now? Would it help our child if we sign now?'" Connor says. "We say, 'No, you can take it easy and not do anything right now. You need time to think about this tonight.'"
Projecting a positive future
It is difficult for families to imagine their lives post the emergency period of dealing with surgeries and investigational treatments. However, part of the job of the clinical research investigator and coordinator is to help them imagine how they will feel about this research study in two, three, four, and even five years time.
"People come from all over the world to get therapies of the kind we offer here," Connor explains. "And what happens is they go back to their lives, and if the therapy really, really works, then they go back to business as usual."
The family might not see their cardiologist anymore because the child is doing well or because they have moved, so it is very hard for them to maintain interest in the follow-up visits, she adds.
"When you get to five years out, it's really hard for families and for clinical research teams," Connor says. "But that's the new way of doing things and it's what the FDA is calling for, so we have to do it."
Community education and informed consent about an investigational treatment will be a more intense process when it involves parents of seriously ill children.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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