$95 million to figure out proper doses for kids

On The Wall Street Journal’s Health Blog, Katherine Hobson profiles the Pediatric Trials Network, a seven-year, NIH-funded effort to determine pediatric dosing information for things like hypertension drugs and antibiotics. The $95-million initiative will fund 16 clinical trials, most of which will enroll 100 to 200 participants, Hobson reports.

Photo by woodleywonderworks via Flickr

Even then, Hobson said, the new study will only make a “dent” in the larger problem. She found that, at present, “virtually all” pediatric drug use is off-label, and that physicians get pediatric dosing wrong about a third of the time. The FDA already does some baseline work to make sure drugs are kid-safe, but the PTN represents a large step beyond present efforts.

Some brand-name drugs do get scrutinized under a program that gives drug makers an extra 6 months of patent protection for conducting FDA-requested studies in kids. And experimental drugs up for FDA approval must assess the effects in kids if they’re likely to use them. But that leaves a big knowledge gap for the host of generic drugs used to treat everything from infectious diseases to cancer.

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