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Research Institutes Launch PGx Investigation in Pediatric Population

NEW YORK (GenomeWeb News) – Three institutions – Boston Children's Hospital, the Medical College of Wisconsin, and the Children's Hospital of Wisconsin Research Institute – have launched a study to assess how genetics can influence pediatric patients' ability to respond to various drugs.

The research partners claim that the trial, called InforMED Kids, is the first pharmacogenetics study to be launched in the pediatric population. Boston Children's is currently enrolling children into InforMED Kids who have conditions that require multiple drugs, such as epilepsy, end-stage renal disease, inflammatory bowel disease, and heart conditions. The researchers may eventually enroll kids with psychiatric conditions.

To date, more than 220 children are partaking in the trial, and investigators hope to enroll 1,000 patients. "Ultimately, our goal is to offer this testing to all patients at the hospital," Shannon Manzi, the study's principal investigator at Boston Children's Department of Pharmacy, said in a statement.

The genetic analysis for the study is being conducted at the Medical College of Wisconsin, which offers a broad PGx testing panel. After results are returned to the physicians, the children's parents are invited to discuss them with the doctor.

Families can discuss the information further with a genetic counselor if they feel the need. Investigators plan to gauge whether the families found the PGx information useful in managing the health of their kids.

According to Manzi, as more data accumulates on the genetic underpinning of drug response through InforMED Kids, researchers will store that data in a repository with which they hope to inform and develop treatment guidelines. The PGx information from the study will also be integrated as part of a child's electronic medical record, and the system will alert healthcare providers when a prescribed drug could cause an adverse event. The research partners all have EMR systems in place that are already doing this to some degree.

"The study data will also be used to encourage health insurance companies to reimburse the cost of pharmacogenomic screening," the institutions said in a statement. "Whether current insurers will cover it, and to what extent, is still unclear."

It is estimated that approximately 70,000 children experience adverse drug effects each year in the US.