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We all want the best for our children. While the thought of enrolling your child in a clinical trial may sound scary, but there are plenty of benefits to trial participation.
Some of these benefits include diagnosing, preventing, treating, and sometimes even curing childhood diseases.
However, there are some potential risks to trial participation, too.
Here’s everything you need to know about enrolling your child in a clinical trial.
What is a Clinical Trial?
Clinical trials are studies with volunteers that help researchers learn how to slow, manage, and treat different diseases.
There are different kinds of clinical trials with different intended purposes.
There are also four phases of clinical trials that each help scientists answer different questions.
Participants may not always benefit from a clinical trial, but in many cases, they do.
Alma Lopez, a breast cancer survivor for more than 15 years, also credits her survival to a clinical trial.
“I believe that my participation in the clinical trial helped me get a new medication, which helped me to recover from cancer,” Lopez said.
Are Clinical Trials Safe for Children?
The National Institutes of Health and the Food & Drug Administration (FDA) have established strict rules for conducting clinical trials.
For example, only the most promising experimental treatments are moved into clinical trials, and participant confidentiality is protected throughout the study.
Children who participate in a clinical trial could be offered an experimental product that may or may not benefit them, but by law, there must be a potential clinical benefit to justify the risk of using the experimental product, according to the FDA.
Also, children must generally have the disease or condition being studied, and they cannot be deprived of a treatment necessary for their health while participating in a clinical trial.
To further reduce risks, study participants are closely observed.
“Monitoring for possible side effects generally would be much more intensive in a research study than when a drug is prescribed, or a device used, by a doctor outside of a clinical trial,” according to the FDA.
While no outcome is guaranteed, researchers follow strict guidelines that help ensure the safety of participants.
In other words, “A clinical trial that evaluates an investigational product might be no riskier than your child being treated with an FDA-approved, cleared, licensed or authorized product that has not been evaluated in children,” stated the FDA.
Further, you can take your child out of the clinical trial at any time – just talk to the study team if you want your child to stop participating in the trial.
Importance of Children in Clinical Trials
A child may respond to a new drug or device differently than an adult. After all, children are smaller, younger, more active, and different from adults in many ways.
Therefore, children who participate in clinical trials can help provide researchers with information adults cannot.
For example, pediatric clinical trials can help verify age-appropriate drug dosages and design modifications for medical devices.
“Children’s responses to medical products can’t always be predicted from data collected in studies of adults. As children grow, their bodies change. Those changes can mean children of different ages may experience differences in the effectiveness or side effects of a medical product and, for example, may need a different dosage,” stated the FDA.
Importance of Latinos in Clinical Trials
Ethnic and racial diversity is also important in clinical trials.
This lack of Latino representation makes it harder for researchers to learn more about Latino health and find treatments tailored for this group — which makes up 18.9% of the US population.
There are a variety of reasons why Latinos do not participate in clinical trials, including lack of awareness and access.
Dr. Amelie Ramirez, Director of Salud America! at UT Health San Antonio is one of those people helping tackle this issue. She’s creating new ways to encourage Latinos to volunteer for cancer and Alzheimer’s clinical trials, with support from Genentech, a member of the Roche Group.
Ramirez is showcasing open clinical trials and uplifting the stories of Latino clinical trial participants on her Salud America! website.
“Latinos in clinical trials are not only helping themselves, but they are also building a future with better treatments that can help their families and communities in the future,” Ramirez said.
How Can I Learn More About Clinical Trials?
If you’re interested in enrolling your child in a clinical trial, or enrolling in one yourself, the first step is to talk with your doctor or your child’s pediatrician.
It’s important to get all the information you need to make an informed decision about participating in a clinical trial.
The FDA recommends asking your healthcare provider the following questions:
- What is the evidence that the investigational product might help me/my child?
- How will you check to see if the investigational product is working?
- Are there any concerns that the investigational product could be unsafe?
- How closely will I/my child be monitored if there are problems?
- Who do I call if I’m concerned that there is a problem?
Additionally, the FDA recommends taking notes during your discussion with your healthcare provider to ensure you fully understand the potential benefits and risks of the trial.
You should also ask for contact information for the trial, and before signing any documents, discuss the trial with your child and trusted family members.
Finally, if you’re not satisfied with the information given to you about the trial, trust your instincts, and don’t enroll.
Remember, you can stop participating in a clinical trial at any time.