Today, the FDA's Division of Pediatrics and Maternal Health (DPMH) launched the "Send Your Pediatric Research Questions to FDA"<https://shareyourvoice.ideascalegov.com/a/index> crowdsourcing challenge. DPMH is using this challenge to provide an opportunity for interested stakeholders to submit ideas for research using pooled analyses of pediatric clinical trial data directly to FDA's scientific staff.
In recent years, FDA's scientists have published numerous pooled analyses that have advanced pediatric regulatory science. Pooled analyses have been used to deepen understanding of extrapolation of adult efficacy data, investigate relationships between biomarkers and different clinical endpoints used in regulatory submissions, and explore the use of innovative trial designs in small populations. However, DPMH wants to hear your ideas for research questions with potential to accelerate or inform pediatric drug development that can be addressed with pooled analysis. After this challenge ends, DPMH may select questions for possible future analyses by FDA staff. Please note that individuals who submit research questions will not obtain access to data or collaborate in any new research studies initiated by FDA. Submissions to this challenge must be received by August 20, 2021. Please share this information with other colleagues who may be interested in submitting research ideas. Best regards, Lily Mulugeta, PharmD Associate Director, Policy and Research (Acting) Division of Pediatrics and Maternal Health, ORPURM Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration
