MED13L基金会战略研究计划:未来路线图。

Therapeutic advances in rare disease Pub Date : 2024-11-28 eCollection Date: 2024-01-01 DOI:10.1177/26330040241290252
Rachel Heilmann, Anna Pfalzer, Terry Jo Bichell, Ananya Terala, Alicia Campbell, Dylan Taatjes, Jamal Ghoumid, Chad Grueter, Jennifer Bain, Randy Strich, Vanessa Dias, Kimberly Sokorai, Nicholas Seaver, Kelly Sexton, Kathleen Boychuck
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引用次数: 0

摘要

战略研究计划(SRP)为患者倡导组织提供了一个指南针,为他们的罕见疾病提供了治疗选择。MED13L基金会于2022年通过罕见神经发育障碍患者倡导组织联盟COMBINEDBrain委托SRP进行临床试验准备。MED13L基金会SRP是对MED13L文献的客观评估,包括临床和基础科学知识,以及实现治疗干预所需的临床前试验准备工具的评估。临床评估是通过查阅记录MED13L综合征个体症状和变异信息的文献来进行的。数据被整理并作为摘要呈现,如适用,提供任何独特的基因型-表型。以同样的方式审查科学文献,确定扩展MED13L综合征知识的机会领域。负责加深对MED13L综合征了解的研究人员和临床医生接受了采访,并共享信息以创建一个开放和协作的网络。临床前试验准备工具主要是通过食品和药物管理局的指导方针制定的,用于从实验室到床边的治疗方法的开发。最后,对基金会的基础设施和社区参与进行了评估,提供了优势和机会,以提升形成的纽带,推动以患者为中心的研究向前发展。完成后,该SRP成为MED13L基金会设定优先事项,与研究人员和临床医生分享,并为实现组织目标提供方向的活资源,包括为受MED13L综合征影响的社区提供治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The MED13L Foundation strategic research plan: a roadmap to the future.

A strategic research plan (SRP) serves as a compass for the patient advocacy organizations driving the therapeutic options for their rare disorder. The MED13L Foundation commissioned the SRP in 2022 through COMBINEDBrain, a consortium of patient advocacy organizations of rare neurodevelopmental disorders, working toward clinical trial readiness. The MED13L Foundation SRP is an objective evaluation of MED13L literature including clinical and basic science knowledge interwoven with an assessment of preclinical trial readiness tools necessary for achieving therapeutic interventions. Clinical evaluation is conducted through a review of the literature documenting symptoms and variant information for each individual with MED13L syndrome. Data is collated and presented as a summary, providing any unique genotype-phenotype, as applicable. Scientific literature is reviewed in the same manner, identifying areas of opportunity to expand knowledge of MED13L syndrome. Researchers and clinicians responsible for growing the understanding of MED13L syndrome are interviewed and information is shared to create an open and collaborative network. Preclinical trial readiness tools are largely framed through Food and Drug Administration guidelines for the development of therapeutics from bench to bedside. Finally, the Foundation infrastructure and community engagement are assessed providing areas of strengths and opportunities to elevate the bond formed to drive patient-centered research forward. Completed, this SRP becomes a living resource for the MED13L Foundation to set priorities, share with researchers and clinicians, and provide direction to reach their organizational goals, including therapies for their community affected by MED13L syndrome.

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