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.
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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.