Children Under Represented In Clinical Trials
October 17, 2012

Children Are Under Represented In Clinical Drug Trials, Say Researchers

Michael Harper for — Your Universe Online

[ Watch the Video: Kids Largely Under-Represented in Drug Studies ]

According to a study released earlier this month, there are far fewer drug studies involving children than there are with adults. Furthermore, when these studies do include children, the research that goes into these studies is far less comprehensive than that of adult studies. According to a Duke University study of studies, this places not only the physicians at a “significant disadvantage,” but the children, as well.

Dr. Sara Pasquali is the co-director of the Michigan Congenital Heart Outcomes Research and Discovery Program at the University of Michigan in Ann Arbor and is the first author of this new study. According to Dr. Pasquali, including children in these studies and clinical drug trials could help doctors understand how drugs affect the younger quarter of the population.

"Although children comprise one-quarter of the population in the United States, they are greatly underrepresented in the clinical trial process that is designed to lead to new and better therapies, determine appropriate drug dosages and establish standards of practice,” said Dr. Pasquali, according to HealthDay.

"For the vast majority of therapies used on children every day in the United States and around the world, clinicians lack basic data to support decisions about the correct dosage, the best type of medication to use and the appropriate situations to provide treatment.”

This study was published online in the journal Pediatrics on October 1, 2012.

In researching some 60,000 clinical trials from 2005 and 2010 in the clinical trial registry, Dr. Pasquali and team discovered little more than 5,000 (or 8%) of these trials were actually designed for kids 18 and younger. Additionally, these researchers found that 23% of these trials included infectious diseases or vaccines. A smaller 13% were dedicated to psychiatric or mental health studies.

Many pediatric diseases can be uncommon and quite diverse. Therefore, the researchers believe these smaller numbers of studies involving children could be a response to this fact.

“Many pediatric diseases are relatively rare, as opposed to something like adult coronary artery disease. As a result, it can take much more time to build a research infrastructure, often involving multiple hospitals, to enroll enough patients in a study," explained Dr. Pasquali.

"But with fewer studies to guide therapeutic decisions, treatments and outcomes for young patients often vary widely from center to center."

The research team also discovered the studies involving children were much smaller than their adult counterparts. This, says Dr. Pasquali, makes it even more difficult to determine if the results found within could be applied to a large swath of the population. It would be more helpful, according to Dr. Pasquali and team, to have larger pediatric studies rather than many, smaller ones.

"Conducting clinical trials with children is a complex issue -- they are not volunteers, they are dissimilar in terms of size and disease condition, and the number of patients is a lot less than what we would find among adults," explained the senior author of the study, Dr. Jennifer Li, who is also a member of Duke Clinical Research Institute.

"This analysis provides one snapshot in time, and it's good to know what the research landscape is so that we can address where we should focus our efforts."