背景:进行高质量的卒中试验既复杂又昂贵。通常,这些试验争夺研究人员的注意力和患者的可用性。同时将患者纳入一项以上的研究有可能加速招募到个体研究中。DISCOVERY是一个多中心,缺血性或出血性卒中后认知障碍和痴呆的初始队列研究。应现场调查人员的要求,DISCOVERY委员会审查个别研究,以批准可能同时参与DISCOVERY的研究.本报告的目的是总结委员会审查的研究的特征和结果,以进行可能的共同注册。
方法:此分析涵盖了由发现招募和保留核心的现场管理委员会(SMC)从2020年07月01日至2022年04月26日审查的研究。每个研究的特征包括研究类型,后续访问的数量和长度,以及是否有协议要求的抽血,脑成像研究,或者认知测试.对患者负担和与Discovery的科学重叠进行了评分。主要结果是SMC批准共同注册。
结果:回顾了59项研究,SMC发现69.5%(n=41,21项临床试验;20项观察性研究)适合于联合纳入.更高的患者负担和与DISCOVERY的科学重叠降低了共同注册的批准率。
结论:在DISCOVERY研究网络中同时进行大量不同的卒中研究。然而,约三分之二的研究被认为适合考虑共同纳入.未来的研究应该研究共同注册如何提高试验网络效率。
BACKGROUND: Conducting high-quality stroke trials is complex and costly. Often these trials compete for the attention of researchers and the availability of patients. Enrolling patients in more than one study concurrently has the potential to accelerate recruitment into individual studies.
DISCOVERY is a multicenter, inception cohort
study of cognitive impairment and dementia following ischemic or hemorrhagic stroke. At the request of site investigators, a DISCOVERY committee reviews individual studies for approval of possible concurrent co-enrollment into
DISCOVERY. The purpose of this report is to summarize the characteristics and outcomes of studies reviewed by committee for possible co-enrollment.
METHODS: This analysis covers studies reviewed from 07/01/2020 to 04/26/2022 by the Site Management Committee (SMC) of the DISCOVERY Recruitment and Retention Core. Characterization of each
study included
study type, number and length of follow-up visits, and whether there were protocol-required blood draws, brain imaging studies, or cognitive tests. Studies were scored for patient burden and scientific overlap with
Discovery. The primary outcome was SMC approval to co-enroll.
RESULTS: 59 studies were reviewed, and 69.5% (n = 41, 21 clinical trials; 20 observational studies) were found by the SMC to be appropriate for co-enrollment. Higher patient burden and greater scientific overlap with DISCOVERY reduced the rates of approval for co-enrollment.
CONCLUSIONS: A large number of diverse stroke studies are being run concurrently across the DISCOVERY study network, however, about two-thirds of the studies were considered appropriate for consideration of co-enrollment. Future studies should
study how co-enrollment might improve
trial network efficiency.