Today, the FDA's Division of Pediatrics and Maternal Health (DPMH) launched the
"Send Your Pediatric Research Questions to
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