More Drug Trials Needed for Conditions Affecting Kids: Review

Off-label prescribing common because of lack of research on effects in younger populations

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Although the lack of industry funding of children's drug trials could be viewed as a good thing because industry backing has been shown to introduce biases, "it's tricky because there are limited resources when it comes to nonprofits, so it would limit the amount you can do," Bourgeois explained.

Pharmaceutical companies make a "conscious decision" to exclude children from trials of their drugs because it is more difficult and expensive to recruit children and get parental consent, and they have a higher rate of dropping out of trials, Wertheimer said.

On top of that, the payoff is higher for adults, Mandl said. "There are even larger markets of adult chronic conditions that are in the sweet spot for profitability of blockbuster drugs."

In an effort to spur drug research in kids, the U.S. government has been offering financial incentives to drug companies that carry out pediatric studies for more than a decade.

But, Bourgeois thinks that more is needed. "It should be a combination of financial incentives and some requirements around what drugs need to be tested in children," she explained.

And, in high-income countries, the drugs to treat mental illness should require the most research. "It's really neuropsychiatric conditions that have overtaken physical impairments," Bourgeois explained. "Children might be deprived of effective treatments if clinicians are not willing to use drugs off-label in them."

Wertheimer agreed that greater requirements for pediatric clinical trials might be in order.

"For any drug that has a high probability of being used in children, it wouldn't be a bad idea to mandate that the drug be tested in some population of children," said Wertheimer, who added that drugs such as antibiotics would likely have a large market in children.

In the meantime, the pace of research in children is at least picking up, even if the rate has not been increasing as much as it has for adults, Bourgeois noted.

More information

You can learn more about pediatric studies in children by visiting the Institute of Medicine.

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