# Global Cooperation to Promote Clinical Research in Children

> **NIH FDA R13** · BRIGHAM AND WOMEN'S HOSPITAL · 2022 · $20,000

## Abstract

FDA PA 19-306
Project Summary
 Bierer, Barbara E., M.D.
Global Cooperation to Promote Clinical Research in Children
Project Summary
The Multi-Regional Clinical Trial (MRCT) Center of Brigham and Women’s Hospital and Harvard (MRCT
Center) is a research and policy center created to address the conduct, oversight, ethics and regulatory
environment of clinical trials, with a focus on multinational trials. To do the work, we function as an
independent convener to engage diverse stakeholders from industry, CROs, academia, patients and
patient advocacy groups, non-profit organizations, and global regulatory agencies to address problems in
rigor and integrity of trials. In this submission, we propose to convene a series of 4 meetings, followed by
a large public conference, of industry and academic pediatric trialists, regulators, and patient/patient
advocates to discuss the challenges of pediatric clinical trials. This conference series is highly relevant to
the FDA’s efforts to promote the evidence base of safety and efficacy of drugs, biologics, vaccines, and
devices in the pediatric population through pediatric trials.
Critical to the health of a population is the development and administration of safe and effective
therapeutic products for children. Ensuring that children have access to safe and effective medicines is
contingent upon the conduct of trials that enroll children and yet the smooth conduct of pediatric clinical
trials is hampered by multiple barriers and challenges. The proposed conference series will build on the
preliminary work of a current MRCT Center project that is exploring the ethical, regulatory, privacy and
confidentiality concerns that impede the conduct of global clinical trials in children, with a particular
emphasis on ex-US countries and low- and middle-income countries (LMICs). The proposed virtual
conference series will involve broad international representative from both resource-poor and resource-
rich countries and will delve into the following critical topics:
1. Analyze IRB/REC and regulatory expectations of approaches to pediatric clinical research across
jurisdictions
2. Considerations for pediatric clinical trial networks across geographical boundaries:
 infrastructure, governance, and capacity in a network and network of networks
3. Alternative potential cooperative models for IRB/EC review of pediatric trials
4. Alternative potential cooperative models for regulatory review of pediatric trials
5. Public discussion of models to advance global cooperation in pediatric clinical research

## Key facts

- **NIH application ID:** 10331087
- **Project number:** 5R13FD007293-02
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Barbara E Bierer
- **Activity code:** R13 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $20,000
- **Award type:** 5
- **Project period:** 2021-01-15 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10331087

## Citation

> US National Institutes of Health, RePORTER application 10331087, Global Cooperation to Promote Clinical Research in Children (5R13FD007293-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10331087. Licensed CC0.

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