Publishing of pediatric drug trialsBy HSC Staff Writer • Published: December 19th, 2006
Category: Health in a Heartbeat
Medical research can’t help doctors if they don’t know about it.
Case in point… clinical trials showing how new drugs affect children.
Pediatricians need this information to determine whether young patients can benefit from medications designed for adults.
But historically, seventy-five percent of drug products have insufficient labeling information on dosing, safety or efficacy in pediatric patients.
In 1997, a new law enabled the U-S Food and Drug Administration to ask manufacturers to conduct research needed for pediatric labeling information.
Companies that comply receive six months of additional patent protection for the drug in question.
However, manufacturers aren’t required to publish the research in peer-reviewed journals.
And a study published recently in the Journal of the American Medical Association suggests that could be a mistake.
Researchers conducted an exhaustive survey of research conducted pursuant to F-D-A requests, from 1998 to 2004.
Of two-hundred-fifty-three pediatric trials, only one-hundred-fifteen were published.
That’s less than half.
Among trials that focused primarily on drug safety, only a quarter saw publication.
The study didn’t explore whether some papers were indeed submitted to journals but were subsequently rejected.
Nonetheless, researchers suggested two strategies might encourage publication of all F-D-A-requested trials. One would be an arrangement where all unpublished data appeared in a journal supplement after a time limit elapsed. Another would be to reward manufacturers that published their studies in peer-reviewed journals. Either way, it’s clear something needs to change. When scientific data is stowed away, doctors… and their patients… suffer from the silence.