Department of Neurology, Division of Developmental Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, USA.
Department of Pediatrics, Duke University School of Medicine, Durham, USA.
J Neurodev Disord. 2022 Mar 23;14(1):22. doi: 10.1186/s11689-022-09435-z.
The recent National Institute of Health (NIH) INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) initiative has bolstered capacity for the current increase in clinical trials involving individuals with Down syndrome (DS). This new NIH funding mechanism offers new opportunities to expand and develop novel approaches in engaging and effectively enrolling a broader representation of clinical trials participants addressing current medical issues faced by individuals with DS. To address this opportunity, the NIH assembled leading clinicians, scientists, and representatives of advocacy groups to review existing methods and to identify those areas where new approaches are needed to engage and prepare DS populations for participation in clinical trial research. This paper summarizes the results of the Clinical Trial Readiness Working Group that was part of the INCLUDE Project Workshop: Planning a Virtual Down Syndrome Cohort Across the Lifespan Workshop held virtually September 23 and 24, 2019.
最近，美国国立卫生研究院 (NIH) 的 INCLUDE（在整个生命周期中调查共病情况以了解唐氏综合征）倡议增强了目前涉及唐氏综合征 (DS) 个体的临床试验能力。这种新的 NIH 资助机制为扩大和开发新方法提供了新的机会，以吸引和有效地招募更广泛的临床试验参与者代表，以解决 DS 个体面临的当前医疗问题。为了抓住这一机会，NIH 召集了领先的临床医生、科学家和倡导团体的代表，以审查现有的方法，并确定需要新方法的领域，以吸引并使 DS 人群为参与临床试验研究做好准备。本文总结了作为 INCLUDE 项目研讨会一部分的临床试验准备工作组的结果：规划虚拟唐氏综合征队列跨越生命周期研讨会于 2019 年 9 月 23 日和 24 日在线举行。
