PDF(Pubmed)
Abstract：
The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community\'s understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials\' efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.
摘要：
中风治疗学术行业圆桌会议（STAIR）在2023年3月22日的STAIRXII会议期间召开了关于急性中风试验注册的会议和研讨会。这个论坛汇集了中风医生和研究人员，国家神经系统疾病和中风研究所的成员，行业代表,和美国食品和药物管理局的成员讨论急性卒中试验的现状和提高纳入的机会。研讨会确定了影响急性卒中试验登记的最相关问题，并讨论了每个试验的潜在行动项目。重点领域包括美国和其他国家的紧急同意；仔细考虑资格标准，以最大限度地提高入学率和代表性；调查员，研究协调员，以及营业时间以外的药剂师可用性；试验热情/平衡；包括合同问题在内的站点启动；站点冠军；尽可能将研究程序纳入标准工作流程；由研究团队使用远程医疗在远程站点集中注册；全球试验；并在可行的情况下参与试验。总之,纳入参与者是急性卒中试验的命脉,也是测试一系列改善患者结局的令人兴奋的新方法的限速步骤.特别是,应努力扩大医学界对紧急同意程序的理解和实施，并采用易于纳入标准工作流程并提高试验效率和执行的设计和流程。与正在考虑的任何单一疗法相比，提高正在进行和未来试验的招募人数的研究和行动将更广泛地改善中风结局。
