08 Dec Is a clinical trial right for your child?

By Callie Rainoseck, Salud America!

We all want the best for our children. While the thought of enrolling your child in a clinical trial may sound scary, 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.

For example, after difficulties fighting cancer, clinical trials saved Timothy Leech’s and Diana Lopez’s lives.

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. Read more …