Researchers Boost Efforts to Recruit Children for Pediatric Drug Trials, Prompts Ethical Concerns
A shortage of children available for testing the safety and efficacy of pediatric drugs has led researchers and pediatricians to increase their recruitment efforts, the Wall Street Journal reports. According to the Pharmaceutical Research and Manufacturers of America, there are currently 194 medicines and vaccines in development for children. Nearly 60,000 children participated in clinical trials last year to evaluate new drugs and study those already on the market. But researchers say "far more" children are needed. Some trials are offering cash, gift certificates to Toys R Us and Tower records and T-shirts, among other incentives. But even with these enticements, 50% of pediatric studies are "in crisis mode due to failed patient recruitment efforts," Kathleen Drennan of Patient Quest, an agency that recruits participants for clinical trials, said.
The search for new recruits for pediatric trials, the number of which have increased significantly since Congress passed a law in 1997 giving drug companies who study their medications' effects on children a six-month patent extension, is "raising complex ethical questions about how to attract more kids and how to make sure those who do sign up understand what they're getting into," the Journal reports. Despite federal regulations mandating that parents give informed consent when agreeing to place their child in a clinical trial, some parents "feel unduly pressured, especially when their child is gravely ill." In addition, some parents and advocates are concerned about the motivation of pediatricians who steer patients into trials. Although it is illegal for the drug industry to offer doctors cash "bounties" for recruiting children, some researchers are "rewarded in other ways," the Journal reports. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital/Partners HealthCare System, conducted a survey of academic researchers and found that nearly four out of five received compensation in the form of research fees, equity or "consulting payments" from drug makers. Another cause for concern are the risks involved in clinical trials, which are "magnified" for child participants. The Office of Human Research Protection has asked a federal advisory committee to more clearly define "minimal risk," one of the standards for pediatric trials. Still, the Journal reports, the prospect of free medication and "intense medical supervision" offered in clinical trials remains a persuasive incentive for parents of sick children (Zimmerman, Wall Street Journal, 5/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.