Global Cooperation to Promote Clinical Research in Children

FDA PA 19-306 项目摘要 Bierer，Barbara E.，M.D. 全球合作促进儿童临床研究 项目摘要 布里格姆妇女医院和哈佛的多区域临床试验（MRCT）中心（MRCT 中心）是一个研究和政策中心，旨在解决行为，监督，道德和监管问题。 临床试验环境，重点是跨国试验。为了完成这项工作，我们作为一个 独立召集人，让来自行业、CRO、学术界、患者和 患者倡导团体、非营利组织和全球监管机构，以解决 严格和完整的审判。在本文件中，我们提议召开一系列的4次会议， 一次大型公开会议，由行业和学术儿科试验者、监管机构和患者/患者参加 倡导者讨论儿科临床试验的挑战。该系列会议高度相关， FDA努力促进药物、生物制品、疫苗和 通过儿科试验，在儿科人群中使用器械。 对人口健康至关重要的是发展和管理安全有效的 儿童治疗产品。确保儿童获得安全有效的药物是 这取决于招募儿童的试验的进行，但儿科临床试验的顺利进行， 审判受到多重障碍和挑战的阻碍。拟议的会议系列将建立在 当前MRCT中心项目的初步工作，该项目正在探索伦理、监管、隐私和 保密问题阻碍了全球儿童临床试验的开展，特别是 重点是美国以外的国家和中低收入国家（LMIC）。建议的虚拟 会议系列将包括来自资源贫乏和资源贫乏的广泛国际代表， 并将深入研究以下关键主题： 1.分析IRB/REC和监管机构对儿科临床研究方法的期望， 法域 2.跨地域儿科临床试验网络的考虑因素： 网络和网络的网络中的基础设施、治理和能力 3.儿科试验IRB/EC审查的其他潜在合作模式 4.儿科试验监管审查的替代潜在合作模式 5.公开讨论推进儿科临床研究全球合作的模式

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