Journal article
Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations
Stroke (1970), Vol.54(10), pp.2698-2707
10/2023
DOI: 10.1161/STROKEAHA.123.044149
PMCID: PMC10542906
PMID: 37694403
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.
Details
- Title: Subtitle
- Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations
- Creators
- Joseph P. Broderick - University of CincinnatiGisele Sampaio Silva - Hospital Israelita Albert EinsteinMagdy Selim - Beth Israel Deaconess Medical CenterScott E. Kasner - University of PennsylvaniaYasmin Aziz - University of CincinnatiJocelyn Sutherland - Revalesio (United states)Edward C. Jauch - Mountain Area Health Education CenterOpeolu M. Adeoye - Barnes-Jewish HospitalMichael D. Hill - University of CalgaryEva A. Mistry - University of CincinnatiPatrick D. Lyden - Zilkha Neurogenetic Institute, Keck School of Medicine of USC (P.D.L.)J Mocco - Mount Sinai Health SystemElaine M. Smith - AbbVie (United States)Macarena Hernandez-Jimenez - Universidad Complutense de MadridEmir Deljkich - Clinical Affairs, Imperative Care (E.D.)Hooman Kamel - Cornell UniversityFana AlemsegedKaren BatesNirav R. BhattJohannes BoltzeBruce C.V. CampbellChristopher FavillaDavid FiorellaJames GrottaWalid HaddadJeremy J. HeidtDavid S. LiebeskindNathan LightfootRonald JubinPooja KhatriMaarten G. LansbergJohn LynchDavid H. MargolinThanh N. NguyenRaul G. NogueiraEdgar A. SamaniegoJeffrey SaverLee H. SchwammKevin N. ShethWendy J. SmithManish WadhwaAjay K. WakhlooLawrence R. WechslerYunyun XiongKori S. ZachrisonStroke Treatment Academic Industry Roundtable (STAIR) XII Participants
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.54(10), pp.2698-2707
- DOI
- 10.1161/STROKEAHA.123.044149
- PMID
- 37694403
- PMCID
- PMC10542906
- NLM abbreviation
- Stroke
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Language
- English
- Electronic publication date
- 09/11/2023
- Date published
- 10/2023
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984463081402771
Metrics
12 Record Views