PEDIATRIC DRUG STUDIES BECOMING LARGER, MORE EXPENSIVE, STUDY SAYS

Pediatric drug study costs increased nearly eightfold between 2000 and 2006, while the studies have become larger and more frequent, a study from the Tufts Center for the Study of Drug Development said.

The total cost of completing a pediatric study involving an already marketed drug rose from $3.93 million in 2000 to $30.83 million in 2006, according to the study, which was requested by the FDA. The increase is consistent with general increases in cost, length and complexity for developing new drugs, the center added.

Pediatric studies have become larger, longer and more numerous under an FDA program to encourage pediatric research. Since the program began in 1998, studies have been conducted on more than 100 diseases and led to new labeling for 120 newly approved drugs in children, the center said.

The agency accepted 568 studies in 2006, up from 58 in 2000, the center added.

The mean number of patients required for FDA-requested studies rose 178 percent between 2000 and 2006, and the mean number of studies per request increased 60 percent, according to the study. In addition, pediatric studies nearly doubled in duration since 2000.