“If her data from her vaccination is able to help other children get vaccinated more safely and more swiftly then it seemed worth it to us,” Amy explains. “Somebody’s kid has to be the kid, so why not ours who can get the vaccine sooner and be one of the ones to help other kids?” As a neuroscientist, Amy was familiar with the process of a clinical trial. While she was a bit worried about an adverse reaction, she says she was more concerned her daughter would be the one to receive a placebo. “She actually did get the placebo at first,” Amy says. “[Six months later] they offered for her to get actually vaccinated and still be part of the trial. So we did that and basically restarted the whole trial, which turned out to be a happy blessing.” Amy’s daughter was one of the thousands of children who volunteered to test the COVID-19 vaccine’s efficacy before it was put out for general use. New vaccines are just one type of clinical trial children are able to participate in. Researchers utilize clinical trials in different ways to test the safety or efficacy of a product before it is on the market. Clinical trials may also be used to test diagnostic measures. While clinical trials are vital to the development of evolving medicine, some parents may have mixed feelings about volunteering their children to participate.
What Is a Clinical Trial?
A clinical trial is a voluntary research study and a way to get reliable evidence in order to answer a specific question. Along with providing necessary information for medical research, clinical trials may provide treatment options not otherwise available. That treatment could potentially help a child with their condition or disease. According to the Food and Drug Administration (FDA), clinical trials provide specific information to guide the agency’s review of medical products. It helps the process of approving, clearing, and licensing those products. The information could also steer product labeling—for example dosing information for a particular medication. Since they are research studies, clinical trials often involve a control group to compare data against. This means if your child is participating in a clinical trial, they may be given a placebo and not the actual treatment. You most likely won’t know that information during the trial. Children are considered a unique population, which is why it is so critical for them to participate in clinical trials. “Often we’ll see the sentence that ‘children are not small adults,’" explains Aditya Gaur, MD, the director of clinical research, infectious disease with St. Jude Research Hospital. “It’s very important that the clinical trial looks at the population it intends to answer the question for. One should not be answering questions for children based on doing clinical trials just in adults.”
Would My Child Benefit From a Clinical Trial?
If you have a child with a condition or disease, being involved in a clinical trial may give them access to treatment they otherwise would not have. In order for parents to determine the potential benefits of participating in the trial, Dr. Gaur says they should have open and detailed conversations with medical professionals. He advises parents to ask questions like—what the trial is trying to find out, what is known about the potential risks in clinical trials, and what the possible benefits are. “So think of questions, write them [down], and ask the questions of the investigator who’s doing the trial if she or he is available," Dr. Gaur suggests. Parents could also discuss their questions with their child’s pediatrician,” These were the sorts of questions Amy was asking before she signed her daughter up to participate in the COVID vaccine trial. She also found it helpful to prepare for any potential negative outcomes. “It’s really important to ask yourself how you will handle it if your child has an adverse reaction. Will you blame yourself? Will be upset with yourself? Will your spouse be upset with you and how will you handle that?” Amy says. “Be honest with yourself that if you don’t handle that, well, maybe this isn’t right for you.”
Are Clinical Trials Safe For Children?
In general, clinical trials undergo an immense amount of scrutiny before they are approved, regardless of the target population. Since children are considered a vulnerable community, they are not allowed to participate in a trial where there is no potential benefit to them. “If there is a clinical trial being planned for a child with no benefits, then risks have to be relatively low or very low,” Dr. Gaur says. “And it should be done in children who have the particular condition that that trial is trying to address so that there may be a potential benefit in the future.” Kids also cannot consent for themselves, which means these safeguarding practices are strict when it comes to medical research and testing. As Dr. Gaur explains, signing up to be a part of a clinical trial is not like entering into a contract to buy a house. “It’s always a process where at any point, someone may choose to come out from a clinical trial and hence underscoring the voluntary piece of it,” Dr. Gaur says. Not all studies are trial-based, Dr. Gaur adds. Some clinical research is less risky but just as important and happens in the form of surveys and questionnaires to answer big questions.
How Do I Find a Clinical Trial For My Child?
Amy found her daughter’s clinical trial relatively easy being at the height of the pandemic and a call for vaccine trial volunteers was on the national news. Other trials are harder to come across. Connecting with a clinical trial usually happens one of two ways: a parent is actively searching for it because their child has a specific medical need or a doctor invites a patient they believe would make a good candidate. Clinical trials can also be found through advertisements and fliers from the researchers. Above all, Dr. Gaur says it’s critical for parents to take their time before deciding whether or not to enroll, ask lots of questions, make sure they have informed consent, and always follow their instincts.
