Results of drug trials in kids often not published

NEW YORK (Reuters Health) - The results of trials that assess the safety and effectiveness of adult-approved drugs in children are usually not published, new research suggests.

Drugs are frequently administered "off-label" to children because many agents have only been tested in and approved for use in adults. As such, medications are often given to children without fully knowing if the effect will be beneficial, harmful, or neither.

To address this problem, the US Congress passed the Food and Drug Administration Modernization Act in 1997, which, in part, extends the exclusive marketing rights for a particular drug if the drug company conducts FDA-requested trials of its use in pediatric populations. Since this "pediatric exclusivity" program was implemented, more than 100 labeling changes to reflect use in children have occurred.

Despite the success of the program in bring about labeling changes, it has been unclear how often the results of these trials actually reach practicing doctors.

In a study reported in the Journal of the American Medical Association, Dr. Daniel K. Benjamin, from Duke Clinical Research Institute in Durham, North Carolina, and colleagues assessed the publication of results of trials conducted to obtain pediatric exclusivity.

From 1998 through 2004, a total of 253 studies for pediatric exclusivity were conducted. Fifty percent of these studies focused on drug effectiveness, 33 percent on drug dosing, and 17 percent on safety. The authors found that 127 of the studies led to labeling changes.

The results of just 113 of the studies were ever published. Predictors of publication included a focus on effectiveness and a labeling change.

"The pediatric exclusivity program has been extremely successful in bringing about labeling changes where indicated, but additional efforts are needed to better inform the medical community about these changes and the studies behind them," Benjamin said in a statement. "Not having this information can be detrimental to patient care."

SOURCE: Journal of the American Medical Association, September 13, 2006.