The Biotechnology Industry Organization (BIO) and the ViS Research Institute (ViS) announce a new initiative aimed at improving the efficiency of clinical development for pediatric therapeutics. BIO and its member companies will work with ViS to use its online analytics platform to evaluate global pediatric clinical research infrastructure, identify pediatric patient populations, and empower clinical research collaboration.
The U.S. FDA and European Medicines Agency require pediatric study plans before approval of new therapeutics. Drug developers have difficulty finding qualified sites that can recruit patients for pediatric trials.
“Leveraging big data sources such as ViS Analytics can help drug developers identify patients to enable streamlined enrollment and site selection, making it faster and easier to conduct pediatric clinical trials and, ultimately, deliver treatments and cures to children suffering from life threatening and debilitating diseases such as epilepsy, hepatitis and diabetes,” said BIO President and CEO Jim Greenwood. “By working with ViS Research Institute, BIO and our member companies will empower pediatric clinical research worldwide.”
BIO member companies, pediatric research centers, regulators and especially pediatric patients will benefit from this initiative, as it will reduce the barriers to global pediatric clinical research. New analytics on pediatric clinical research infrastructure and patient populations will be available in the coming months on ViS' collaborative analytics platform.
“Innovative research approaches are needed to improve success in these most challenging pediatric drug development programs with more timely access for these new drugs in children,” said Dr. Ron Portman, Chair of BIO’s Pediatrics Committee.
Approximately 60% of the disease burden for high priority conditions like schizophrenia, depression, malaria, and HIV/Aids, is borne by children, though only about 12% of clinical trials are pediatric, according to the American Academy of Pediatrics.
When a disease is indicated in pediatric populations, pediatric trials are required to assess whether a drug that is effective in adults will be effective in children, or require a different dose, and whether its safety profile is similar or different when given to children. Additionally, the medication must be provided in age appropriate formulations that are acceptable to children. Often, important pediatric research is abandoned for reasons of impracticality or impossibility, according to the Institute of Medicine.