During the BPCA Stakeholders Meeting in December 2020 (PDF 218 KB), speakers shared updates on current work within the BPCA program as well as identified challenges and gaps in pediatric drug development and therapeutics. They also discussed the development of a generic framework: an annotated, selective, curated collection of resources to assist drug developers, researchers, and clinicians with a universal resource of relevant topics (existing resources and remaining gaps) before conducting pediatric drug development research.
To continue this effort, stakeholders were invited to participate in and provide subject matter expertise on the next steps in developing this framework. Part of this commitment included participation in public assemblies to evaluate resources for the framework.
In 2021, BPCA stakeholders convened six public assemblies, each of which focused on providing recommendations for existing resources that can be made available for those who conduct and/or sponsor pediatric drug development research. The assemblies focused on the following topics:
- Advancing Clinical Trial Designs and Conduct in Pediatric Drug Development
- The Role of Pharmacodynamic Biomarkers Research in Pediatric Drug Development
- How Pharmacokinetic Modeling Can Be Used to Inform Drug Dosing
- Enhancing Research in Pediatric-Friendly Formulations
- The Role of Pharmacoepidemiology in Pediatric Drug Development
- The Role of Quantitative Systems Pharmacology in Pediatric Drug Development
Further discussions were held at the 2021 BPCA Stakeholders Meeting (PDF 319 KB), where gaps in knowledge were also discussed along with proposed solutions.
As a result of this work, the BPCA Framework to Enable Pediatric Drug Development (PDF 1.4 MB) was prepared and serves as a comprehensive collection of resources for those involved in pediatric drug development research. A curation plan is being implemented to ensure the framework stays current and relevant. Using identified gaps in knowledge and areas of need, the NIH Library will conduct an annual review of new resources in each assembly area. Resources will be reviewed by NICHD staff and selected reviewers prior to being added to the framework. Resources will be removed when it is determined that more current documents address the same gaps, information is outdated, or information is duplicative. Public input is welcome and encouraged.
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