Looking for opportunities to co-enroll: The DISCOVERY study experience.

Looking for opportunities to co-enroll: The DISCOVERY study experience.
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寻找共同注册的机会:DISCOVERY 学习体验。

DOI:
10.1016/j.jstrokecerebrovasdis.2022.106862
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发表时间:
2022
期刊:
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
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文献类型:
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作者:
Anisetti,Bhrugun;Rost,Natalia;Barrett,Kevin;Gottesman,Rebecca;Graff-Radford,Jonathan;Kittner,Steven;Boden-Albala,Bernadette;Cissel,Heather;Mills,Brittany;Carman,Kaley;Vemuri,Prashanthi;Wruck,Lisa;Bhapkar,Manjushri;Donahue,Katy;

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BackgroundConducting 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.MethodsThis 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.Results59 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.ConclusionA 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.