Global Cooperation to Promote Clinical Research in Children

FDA PA 19-306 项目概要 比尔勒，芭芭拉·E.，医学博士 全球合作促进儿童临床研究 项目概要 布莱根妇女医院和哈佛大学的多区域临床试验 (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，我们的职能是 独立召集人，让来自行业、CRO、学术界、患者和医疗机构的不同利益相关者参与进来 患者权益团体、非营利组织和全球监管机构共同解决以下问题： 试验的严谨性和完整性。在本次提交中，我们建议召开 4 次系列会议，然后 由行业和学术儿科试验者、监管者和患者/患者参加的大型公开会议 倡导者讨论儿科临床试验的挑战。该会议系列与以下内容高度相关： FDA 努力促进药物、生物制品、疫苗和药物的安全性和有效性的证据基础 通过儿科试验在儿科人群中使用设备。 对人口健康至关重要的是安全有效的药物的开发和管理 儿童治疗产品。确保儿童获得安全有效的药物是 取决于招募儿童的试验的进行以及儿科临床试验的顺利进行 试验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正在探索道德、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 重点关注美国以外的国家以及低收入和中等收入国家 (LMIC)。拟议的虚拟 系列会议将有来自资源贫乏地区和资源匮乏地区的广泛国际代表参加 富裕国家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 司法管辖区 2. 跨地域儿科临床试验网络的考虑因素： 网络和网络网络中的基础设施、治理和能力 3. IRB/EC 儿科试验审查的替代潜在合作模式 4.儿科试验监管审查的替代潜在合作模式 5. 公开讨论促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