Clinical Trials for Kids

The market for prescription pediatric drugs worldwide is expected to approach $43 million by 2011, according to Kalorama Information Research. There are approximately 2.5 billion children in the world, representing 40% of the population. Most drugs in development for children are in the areas of genetic diseases including cystic fibrosis, Gaucher disease, and hemophilia; and infectious diseases, including head lice, influenza, and RSV.

Medicines in Development for Children

While the drugs in development for pediatrics cover a horizontal therapeutic market, conducting trials in children is not a one-size-fits -all enterprise.

In November, Peter Joiner, Chief Executive Officer of Madeira Therapeutics, which conducts pediatric trials, told Applied Clinical Trials in a podcast that both children and parents need to be comfortable in order to participate in a pediatric trial. So investigative sites need to accommodate the family and be "kid friendly." Strategies include bright colors, friendly people, flexible scheduling, and an overall welcoming environment.

However, a recent study appearing in Pediatrics (March 29, 125: e876-e883) and covered as a news item on Medscape, shows issues specific to the pediatric consent process. This study indicated that a full 86% of children participating in oncology trials did not understand what their doctor was saying to them about the trial, and that the decision was more in the hands of their parents and doctors. The authors of the study said that the findings mean that enhanced communication between the pediatric oncologists and the families would help improve the assent/consent process. Felix Khin-Maung-Gyi, Chief Executive Officer of Chesapeake Research Review, told us that the study shows "we have a long way to go in terms of the general populations understanding of research and the role of participation."