The Biotechnology Industry Organization and the ViS Research Institute have launched an 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 FDA and EMA require pediatric study plans before approval of new therapeutics. According to BIO, 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.”
The initiative aims to reduce the barriers to global pediatric clinical researching, benefitting BIO member companies, pediatric research centers, regulators and, especially, pediatric patients. 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 including 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 acceptable to children. Often, important pediatric research is abandoned for reasons of impracticality or impossibility, according to the Institute of Medicine.
The ViS Research Institute is dedicated to the optimization of global clinical research. Its platform offers multi-dimensional analytics for research center evaluation, while enabling the more than 400,000 disease-specific research centers worldwide to efficiently display their capabilities. The analytics are made easily accessible through interactive visualizations and user-friendly search tools, which answer trial planning questions at a small fraction of the time spent and cost incurred through conventional methods. ViS was created as a global enterprisein 2010, and has regional hubs in New York City, São Paulo, Mumbai and Frankfurt.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the U.S. and 30 other nations.