A new look at pediatric type 1 diabetes drug development
By: J. Rick Turner, PhD, DSc, FASH, FACC | November 17, 2015
The number of children diagnosed with pediatric type 1 diabetes continues to grow across the globe. In response, throughout the last two decades new insulins and devices have been developed, tested, and approved for use in children. However, the current reality is that most children and adolescents do not reach the targets for metabolic control set by organizations such as the International Society for Pediatric and Adolescent Diabetes and the American Diabetes Association.
One complicating factor is that we cannot approach diabetes drug development among children the same way we do for adults. In the world of medicine, children are not simply ‘little adults.’ For example, pediatric patients may metabolize a drug differently than adults and they may experience side effects not relevant to adult patients, such as impact on growth or pubertal development. It is therefore very important that pediatric patients be included in development programs for drugs that will be prescribed to children, and there is legislation in many countries around the world addressing this issue. However, many challenges still exist in pediatric drug development.
Recently, a group of experts including Quintiles published a paper in the peer-reviewed journal Diabetes Care exploring different approaches to pediatric type 1 diabetes drug development and regulatory approval. While the paper focuses on the U.S. Food and Drug Administration, many aspects of the analysis are widely applicable in other countries too.
Ten actionable suggestions were offered in an effort to improve pediatric type 1 diabetes drug development, including:
Chief Scientific Advisor, Quintiles Cardiac Safety Center of Excellence