NIH, in consultation with the U.S. Food and Drug Administration (FDA) and experts in pediatric research, is mandated to:
- Develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that require study, and update this list every 3 years.
- Consider the following information in developing and prioritizing the list:
- Therapeutic gaps in pediatrics, including developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials
- Pediatric diseases, disorders, or conditions where more complex knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations
As part of the prioritization process, NICHD solicits nominations from BPCA stakeholders to be considered for priority areas for the following year. These nominations are reviewed, scored, and tiered by expert volunteers. A sample nomination form is available for review (PDF 69 KB). The BPCA Priority List of Needs in Pediatric Therapeutics is then created and informs trials conducted by the Pediatric Trials Network.
To submit a drug, biologic, or medical device to be considered for prioritization in 2022-23, see the Request for Information and visit the nomination submission form at https://www.surveymonkey.com/r/BPCAPrioritization2022
. Nominations must be received by July 25, 2022. Contact bpca@infinityconferences.com with any questions about the nomination process.
Nomination
Solicitation
Nomination
Review
BPCA Priority
List of Needs
in Pediatric
Therapeutics
Trial Design
- BPCA Stakeholders
- NIH Liaisons
- Annual BPCA Meeting
- Volunteer reviewers
- Scored based on evidence, population, impact
- Three tiers of nominations
- BPCA NICHD Working Group review
- FDA review
- Updated list of priorities
- Top tiered/scored nominations
- Listed by therapeutic area
- Pediatric Trials Network
- Other BPCA Collaborations (other areas of research)
Nomination Solicitation
- BPCA Stakeholders
- NIH Liaisons
- Annual BPCA Meeting
Nomination Review
- Volunteer reviewers
- Scored based on evidence, population, impact
- Three tiers of nominations
- BPCA NICHD Working Group review
- FDA review
BPCA Priority List of Needs in Pediatric Therapeutics
- Updated list of priorities
- Top tiered/scored nominations
- Listed by therapeutic area
Trial Design
- Pediatric Trials Network
- Other BPCA Collaborations (other areas of research)
The BPCA convenes Working Group Meetings on specific therapeutic areas. The working groups include national expert scientists, researchers, and clinicians, along with representatives from NICHD and the FDA. These groups hold regular teleconferences and virtual meetings to fulfill their two primary charges:
- Discuss scientific questions that need to be addressed for drugs and indications in that Working Group’s area of expertise. Considerations must be within the context of the current FDA-approved lael (if it exists), noting specifically where pediatric information is underdeveloped or lacking.
- Consider the practicalities (given the scope and funding of the BPCA) of conducting additional studies of the drug and/or indication of interest.
Meeting minutes from all BPCA Working Groups are available in the Archives.