More Drug Trials Needed for Conditions Affecting Kids: Review

HealthDay – 6 mins ago WEDNESDAY, July 25 (HealthDay News) -- A new review finds that while children account for almost 60 percent of those with five common medical conditions, only 12 percent of clinical trials of drugs for those conditions examined their effects on pediatric patients.

Yet, the review authors noted, previous research has shown that off-label drugs, where the medicine has only been approved for adult use by the U.S. Food and Drug Administration, make up as much as 79 percent of the medications given to children in hospitals and up to 56 percent of drugs prescribed for kids in doctors' offices.

"We think this contrast is striking, and speaks to the under-representation of research on kids," said review author Dr. Florence Bourgeois, an assistant professor of pediatrics at Boston Children's Hospital and Harvard Medical School in Boston. "Understandably, whenever we see an adverse event the concern is, 'Could these drugs really be dangerous?' and we are left wondering."

The results were released online July 23 in advance of publication in the August print issue of the journal Pediatrics.

The FDA requires that clinical trials demonstrate a drug's safety and effectiveness for a condition before it approves the drug to treat that condition, but many drugs are only tested in adults. As a result, physicians are often left to rely on trial-and-error to decide how to use drugs off-label in children, the review noted.

Bourgeois and her team found that, while just over 21 percent of people in high-income countries who are afflicted by conditions such as depression, asthma, migraines, schizophrenia and bipolar disorder are children and adolescents, less than 10 percent of clinical trials studying these conditions included patients under the age of 18.

The gap was even wider for developing countries, where children and adolescents bear nearly 62 percent of the disease burden for conditions such as malaria, diarrhea, HIV and depression, but only about 12 percent of clinical trials of treatments for these diseases include pediatric patients.

A number of professional organizations, including the Institute of Medicine, the American Academy of Pediatrics and the Royal College of Paediatrics and Child Health in England, have all published statements on the importance of evaluating medical treatments for children using randomized, controlled trials. A randomized, controlled trial, in which study participants are randomly chosen to either receive a treatment or not, is the gold standard for medical research.

"In some instances, it may be fine to extrapolate adult

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