Clinical trials are no child’s play

| Updated on January 15, 2018

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You may have heard of clinical trials and your doctor may even have suggested your child enroll in one. Clinical trials are voluntary research studies conducted on people to answer specific questions about the safety and/or effectiveness of drugs, vaccines, new ways of using treatments, etc. If your child were to enroll in one, he or she could be offered a new treatment that may (or may not) be better than those already in practice, explains the United States Food and Drug Administration (USFDA).

By law, giving a study drug to children must provide a potential for clinical benefit that justifies the risk of administering the drug, and the children who participate must have the disease or condition being studied. Under limited circumstances, children may be exposed to the risks of a drug that does not offer any clinical benefit, provided that the risks are sufficiently low and the information to be gained is important to understanding or improving the disease or condition.

Such trials yield important information on a drug’s safety, dosing, effectiveness, etc., the basis for any USFDA approval. It also appears on the product’s label. Only about 50 per cent of drugs approved by the USFDA are for use in children. By necessity, doctors routinely treat children with a drug that has been approved for adult use, but may be untested in children.

Children’s responses to drugs can’t always be predicted from studying adult data. A child’s metabolism changes as he or she gets older. So, how a drug affects a newborn may be quite different from how it affects an adolescent.

Depending on the trial, a child may get an experimental drug, a treatment known to be effective, or an inactive pill (placebo). Also, if a child has ongoing treatment for, say, seizures and is taking medication for it, that would continue alongside the experimental drug being studied in the trial.

Source: USFDA

Published on April 14, 2017

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