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
FDA PA 19-306 Bierer, Barbara E., M.D. Project Narrative Global Cooperation to Promote Clinical Research in Children Project Narrative This proposal will fund a series of 4 meetings, followed by a large public conference, over a 2.5 year period to explore targeted aspects related to the ethical and regulatory concerns that impede the conduct of global clinical trials in children. The series will delve into a range of topics: (1) the differences across jurisdictions of approaches to pediatric clinical research, including IRB/REC and regulatory expectations; (2) considerations for pediatric clinical trial networks across geographical boundaries: infrastructure, governance, and capacity in a network and network of networks; and alternative potential cooperative models for (3) IRB/EC and (4) regulatory review of pediatric trials. The fifth and final meeting, a large public conference, will entail a public discussion of models to advance global cooperation in pediatric clinical research. Of importance is the intent to involve international representatives, from both resource-poor and resource-rich countries. This will ensure a global presence in the discussions and ultimate development of recommendations and potential solutions to the challenges encountered in the conduct of pediatric global clinical trials. It is our intention to promote the dissemination of the work broadly through the distribution of all meeting summaries, developed for industry and academia as well as for the general public. We plan to publish in the peer-reviewed literature and on public platforms describing the issues and considerations discussed during the public conference, and if agreement is reached, suggestions for future work.
