Children in Clinical Trials: How Safe It Is?

How a certain drug or therapy will affect children is very hard to predict based on clinical trials/studies conducted on adults alone. Every age group has specific needs and specific reactions to chemicals or therapy methods, yet children are often given medicine proven safe in adults but with unknown effects in children (up to 70% of the medicines given to children have been tested only in adults).

Sometimes the drug is simply tested in a different age group (tested in pre-adolescents but given to infants for example) and while safe, it might be ineffective or the dose might need to change based on the trial-error method when there is a lack of data and thus, a recommended dose for the particular age group.

Read “The 5 Most Popular Myths About New Drugs — Debunked (Infographic)”

That’s why child participation in clinical trials is crucial. By law, in order for a clinical trial to be open for children, the drug or therapy must first a) prove that the health benefits significantly outweigh the risks, or b) prove that even though it doesn’t benefit the participants as much, the risks are low enough to justify a trial being conducted, and the information that could be gained is of utmost importance to understanding or treating the condition.

a) prove that the health benefits significantly outweigh the risks, or

b) prove that even though it doesn’t benefit the participants as much, the risks are low enough to justify a trial being conducted, and the information that could be gained is of utmost importance to understanding or treating the condition.

Also, when talking about risks, you should know that in some cases taking an experimental drug might actually be safer for the child than being treated with a drug only tested in adults. A potential benefit of participating in a clinical trial in such cases could be the more intensive monitoring.

But what about consent? As you know, a minor can’t give legally binding consent, so it’s up to the parent or guardian to enroll the child into a clinical trial. However, a child of a certain age should have the right to take equal part in the decision based on all the available information about the potential risks and benefits (explained to them in an age-appropriate way) – just like adults do. The parent or legal guardian can consult a pediatrician – the pediatrician can also provide some support for both the child and the parent during the clinical trial itself. As with adult participation, exiting the clinical trial at any time is still a patient’s prerogative – informed consent can be withdrawn.

Out colleague Boryana Krasteva’s study found out that 30% of children with cancer participate in clinical trials compared to only 3% of adults. As with any other condition, cancer in children progresses in a different way, has a different survival rate and allows for a different kind of treatment than cancer in adults.

We already talked about the importance of diversity in clinical trials and how different groups in society may react differently to the same medical therapy (check out our article on minority participation in clinical trials) – the same goes for children. Understanding the way certain conditions develop and progress in children, the side effects of the potential cures as well as the optimal dose to be used is very important and participation in clinical trials significantly increases the chances of that happening.

FMC’s database shows up to 8338 clinical trials open for children based on age criteria alone. One of those trials might develop the next notable cure in the fight against children mortality if given the chance. Use the button bellow or go to our search page and explore clinical trials for various conditions, ages and locations.

On the article worked Nelly Katsarova

Sources:

[1] http://www.childrenandclinicalstudies.org/