ATLANTA, Ga - In partnership with the FDA and other organizations, the International Children's Advisory Network, Inc. (iCAN) supports the ongoing effort to help spotlight the need for acceleration of Pediatric Drug Development through sharing the voice of our youth members, parents and other community stakeholders.
To provide context to the importance of this initiative, the Springer Link Journal noted: "the Therapeutic Innovation & Regulatory Science special section on “Innovation and Opportunities in Pediatric Therapeutic Development” published in 2019, shows progress has been made over the past 15 years with respect to labeling drugs for pediatric patients. Unfortunately, there continues to be an approximately 9-year delay from drug approval in adults to labeling for pediatrics."
Furthermore, Springer Link shared, "Efficient, innovative trials incorporating the voice of the global, ethnically diverse patient/parent population need to be initiated earlier in the drug development paradigm to reduce the off-label use of therapies where information about safety, dosing, and efficacy is lacking or limited in children. The next phase of accelerating pediatric drug development involves the fullest possible use of more complex trial designs and extrapolation while coordinating global pediatric networks, incorporating patients/parents into protocol development, and ensuring ethnic diversity and inclusivity in pediatric trials. In this pediatric special section of Therapeutic Innovation & Regulatory Science, a series of articles propels us into the next phase of pediatric drug development that aims at decreasing the development timeline from adult approval to pediatric labeling. These efforts are focused on innovative trial designs; issues related to rare diseases and pregnant individuals; advances in pediatric formulation development; development of digital technologies in pediatric trials, including the digital capture of clinically meaningful endpoints; an update on pediatric global networks; and a discussion of stakeholder engagement with a focus on health equity and the voices of children and their families. Once again, the mandate is for a public health requirement that ensures the availability of safety and efficacy data for all drugs prescribed for children."
Most recently, two friends of iCAN Dr. Susan McCune, and Dr. Ron Portman, wrote an article entitled, "Accelerating Pediatric Drug Development" for a 2022 Special Issue of Therapeutic Innovation & Regulatory Science. Published September 14th, 2022, the authors review the progress made and discuss the ability to accelerate the availability of medicines for children, they present a historical framework starting with a period of acknowledgement, followed by a period of suggested action and a period of required action, leading to the current period of refinement. To read the article and others, please visit: https://link.springer.com/collections/bcgbbhbggh
To learn more about the scientific community engagement that iCAN has participated in, please visit our section on abstracts and posters at https://www.icanresearch.org/papers-posters. To submit a poster, please contact iCAN President, Leanne West at lwest@gatech.edu.