Should Your Child Participate in a Pediatric Clinical Trial? - Accel Research Sites

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Date Published: 04/12/2017

Should Your Child Participate in a Pediatric Clinical Trial?

This is understandable, since it’s a parent’s natural inclination to protect their child and do what is best for him or her.

However, many of us have also been subjected to false information and negative stigmas surrounding pediatric clinical trials. This research may uncover a new means of protecting your child, or of improving their health. Not to mention that clinical trial volunteers are our real superheroes!

Why Are Children Needed for Clinical Trials?
One of the questions we get asked here at Avail Clinical Research is, “Why are children needed for clinical trials?” Perhaps you might wonder why we can’t just test on adults and then administer to children in smaller doses.

The fact of the matter is that children’s needs are very specific. In the same way we don’t test a potential diabetes drug on someone who suffers from chronic migraine, testing a pediatric drug on an adult would be inaccurate. This is where our little superheroes come into play!

A young participant in a pediatric clinical trial in DeLand
Pediatric clinical studies have the potential to improve thousands, even millions, of children’s lives in the future, and the children in the studies have the potential to benefit from the promising medications. These clinical trials ensure that the following happens before a drug goes to market:

  • We know the appropriate use
  • We’ve established the appropriate dosage
  • We’re aware of any risks or side effects

Clinical studies are crucial to the development of any drug or medical therapy, so we take them very seriously. And when your child helps us advance this important cause, his or her safety is our top priority!

How Are Children Protected?
The FDA has rigid guidelines to ensure the safety of any child participating in a clinical study, and we follow them to the letter.

Some of these safety measures include:

A thorough analysis and final approval of the study protocol conducted by an institutional review board (IRB)

Continuous monitoring of the trial by the following groups:

The aforementioned IRB
The trial’s research team
The sponsoring organization for the trial
Data and Safety Monitoring Boards (DSMBs)
Getting informed consent from both parents of a child under 18. Exceptions may include instances in which one parent:
Has passed away
Is incapable of giving permission
Is not known
Is the child’s sole legal guardian

Did you know that children must also agree to be in the clinical trial? Children’s assent can only be given if the child is capable of understanding what the trial is about and what their role will be. If they know what the trial involves and willingly decide to partake, these superheroes can proceed with saving the day!

Pediatric Clinical Trials in the Media
There are some unfortunate aspects of how clinical trials are presented in the media. First of all, they’re not talked about enough!

Family takes part in a pediatric clinical trial at Avail Clinical Research

Often parents whose children are struggling with a given medical condition haven’t even thought about a clinical trial as a viable option. If they have thought about it, perhaps they’ve read generalized articles with derogatory terms like “guinea pig,” rather than any of the many stories about the times a clinical trial has changed (or saved!) someone’s life.

Another possibility is that they’ve only thought about pediatric research in regard to illnesses such as cancer, and haven’t considered it for something like acute otitis media or influenza. However, clinical research should be seen as an opportunity when it comes to any condition! Just because an ear infection isn’t usually as serious as cancer, doesn’t mean that it’s not important. Your child still has the potential to improve his or her quality of life. If the medicine is effective, he or she benefits physically. Not to mention that helping advance such an important cause will make anyone feel great about their contribution!

Some great news is that other people felt like we do– that clinical trials aren’t being given enough credit for the lives they’ve positively impacted, and that more people need to be told.

This is why we are excited about the new hour-long documentary If Not for Me. This documentary shares the stories of real families who chose to participate in clinical research studies. The film is honest and informative, and could help many families who are currently weighing what is the best decision for their child.

Please check out the trailer on YouTube if you get a chance.

Victoria Pemberton, Project Officer at the National Heart, Lung, and Blood Institute (NHLBI), summarized the documentary’s mission well:

“This project was funded by NHLBI to address the unique issues surrounding pediatric clinical research participation. Parents agree that clinical research for children is important to find new and better treatments, but misperceptions, fears and lack of information often lead parents to forgo enrollment of their children. If Not for Me works to address those misconceptions by highlighting families that have gone through pediatric clinical trials.”

The NHLBI team has expressed how honored they are to have received the Telly Award– and the Avail team is excited this important film is receiving the recognition it deserves. If you are curious to hear about real families’ clinical trial experience, we highly recommend watching it. Who knows how many of your questions might get answered during that hour!

So Should Your Child Participate?
Any parent considering putting their child in a clinical trial weighs the risks against the benefits, so if you’re feeling cautious, you are not alone.

We recommend educating yourself on every aspect of clinical trials and on the study you’re considering in particular. Talk to your doctors, do your own research (using reputable sources), and learn all you can! If you have any questions for us, you can call us at (386) 785-2400.

Here are a few things you should ask yourself:

1) What is the trial’s intended purpose?

2) What are the trial’s potential risks and benefits?

3) How long will the trial last?

4) Are there any advantages over my child receiving standard care? Disadvantages?

5) What will happen if I want to pull my child out?

6) Who will be in charge of my child’s care?

7) What treatments and/or tests will be administered?

8) Who will gain access to my child’s health information?

9) How big of a time commitment is it? This can include:

Duration of site/hospital/clinic visits
Frequency of visits
Commute time

10) Will my family be compensated?

11) Will I have any out-of-pocket costs for transportation, etc?

12) Who will be my point of contact for questions or concerns?

Whew! Hopefully that list didn’t leave you feeling overwhelmed. But like we said, we want you to have a better understanding of pediatric research and how it plays an active role in your child’s health care.

At the end of the day, you’re the only person who can decide what’s best for your child. And whatever that is, our team of Deland physicians, researchers, and superhero-recruiters supports you!


Ready to be part of healthcare history? Find the right clinical trial for you.

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