NOT ALL PEDIATRIC TRIAL RESULTS PUBLISHED, DESPITE FEDERAL PROGRAM

A nine-year-old federal program meant to stimulate pediatric clinical trials has been only partially successful, according to an article in the Sept. 13 edition of the Journal of the American Medical Association (JAMA).

In 1997, Congress passed a "pediatric exclusivity" program that allowed the FDA to grant extensions of marketing rights as a way of inducing companies to conduct pediatric clinical trials. This was meant to tackle the problem of off-label pediatric drug use.

The JAMA article, by Daniel Benjamin and several other authors, examined how successful this program has been. The researchers looked at "all trials conducted for pediatric exclusivity between 1998 and 2004 the subsequent labeling changes, and the publication of those studies in peer-reviewed journals." There were 253 such studies in this period, and labeling changes were positive for 127 of them (50 percent). But only 45 percent, or 113 studies, were published, the JAMA researchers said, adding that, "Efficacy studies and those with a positive labeling change were more likely to be published."

Thus, Benjamin and his co-authors concluded, "The pediatric exclusivity program has been successful in encouraging drug studies in children. However, the dissemination of these results in the peer-reviewed literature is limited. Mechanisms to more widely disperse this information through publication warrant further evaluation."