NONMEM Users Network Archive

Hosted by Cognigen

FDA Launches Crowdsourcing Challenge: Pediatric Research Questions

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Mon, 2 Aug 2021 14:08:39 +0000

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 chal=
lenge to provide an opportunity for interested stakeholders to submit ideas=
 for research using pooled analyses of pediatric clinical trial data direct=
ly to FDA's scientific staff.

In recent years, FDA's scientists have published numerous pooled analyses t=
hat have advanced pediatric regulatory science. Pooled analyses have been u=
sed to deepen understanding of extrapolation of adult efficacy data, invest=
igate relationships between biomarkers and different clinical endpoints use=
d in regulatory submissions, and explore the use of innovative trial design=
s in small populations. However, DPMH wants to hear your ideas for research=
 questions with potential to accelerate or inform pediatric drug developmen=
t that can be addressed with pooled analysis.
After this challenge ends, DPMH may select questions for possible future an=
alyses by FDA staff. Please note that individuals who submit research quest=
ions will not obtain access to data or collaborate in any new research stud=
ies 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 i=
n 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



Received on Mon Aug 02 2021 - 10:08:39 EDT

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to: nmusers-request@iconplc.com.

Once subscribed, you may contribute to the discussion by emailing: nmusers@globomaxnm.com.