Safety oversight a rare feature in child drug trials

Only one of every 50 drug trials involving children assembled an independent safety monitoring group to watch for signs of dangerous side effects, according to a sweeping review of 739 international trials mounted between 1996 and 2002. And the analysts said that among the tiny fraction of trials that utilized a monitoring group, six were stopped due to signs of toxicity. Adverse side effects were reported in 37 percent of all trials and about one in ten recorded side effects that were moderate to severe and occasionally life threatening.

"We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children," Dr. Helen Sammons, associate professor of child health at Nottingham University, told the Guardian.

Sammons went on to note that drug trials for children were still a relatively recent phenomenon. In the past, children were often given the same medicines as adults, with sometimes disastrous results. A child's metabolism is distinctly different from an adult's, raising the risk that they will experience unique adverse events.

- check out this release on the findings
- read the article in the Guardian

Related Articles:
Duke, FDA join forces to overhaul clinical trials. Report
Pediatric program helps spur new drug research. Report
Pilot program to monitor pediatric health. Report
FDA overhauls trial design with new suicide standard. Report