# BPCA PHARMACOEPIDEMIOLOGY (REAL WORLD DATA) STUDIES

> **NIH NIH N01** · DUKE UNIVERSITY · 2021 · $600,000

## Abstract

Since the early 1990s, the scientific community, including academia, NIH, FDA and the
pharmaceutical industry have worked to improve the knowledge of medications used in
children. Congress has passed legislations to provide incentives for drug development plans in
pediatrics. The responsibility for the implementation and oversight for improving drug
development in pediatrics has been delegated primarily to the FDA (for on-patent drugs) and
to the NIH (for off-patent drugs). Even though the legislations have improved the number of
clinical studies conducted in children, gaps remain in areas such as developmental
pharmacology, ontogeny of drug metabolism, the validation of outcome measures and
endpoints in pediatric research, and most recently utilizing databases and electronic health
records (real world health data) to leverage clinical research. After more than 30 years of
legislation, and in the face of burgeoning technological advances in clinical care and research,
it has become clear that to be successful in continuing to close knowledge gaps in the area of
pediatric drug development to appropriately treat pediatric patients for a variety of diseases, an
integrated and comprehensive approach to pediatric drug development research is required.
Furthermore, NICHD and others in the scientific community are concluding that the
harmonization of clinical research data (i.e., PK, pharmacodynamic, pharmacogenomic,
efficiency, and safety data) with the use of existing clinically relevant databases, registries and
other means of collating real world patient health data are vital to the success of effectively
treating pediatric patients in a personalized way.

## Key facts

- **NIH application ID:** 10475400
- **Project number:** 275201800003I-0-759402100001-1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** KANECIA ZIMMERMAN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $600,000
- **Award type:** —
- **Project period:** 2021-08-16 → 2025-08-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10475400

## Citation

> US National Institutes of Health, RePORTER application 10475400, BPCA PHARMACOEPIDEMIOLOGY (REAL WORLD DATA) STUDIES (275201800003I-0-759402100001-1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10475400. Licensed CC0.

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