Abstract
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.
Conclusion
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.
Keywords
Abbreviations:
PSCID (Post-stroke cognitive impairment and dementia), CPS (Clinical performance sites), SMC (Site Management Committee), SOD (Scientific Overlap with DISCOVERY score), PB (Patient Burden score)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 01, 2022
Accepted:
October 24,
2022
Received in revised form:
October 21,
2022
Received:
September 12,
2022
Identification
DOI: https://doi.org/10.1016/j.jstrokecerebrovasdis.2022.106862
Copyright
© 2022 Elsevier Inc. All rights reserved.
