In:
Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. Suppl_1 ( 2023-02)
Abstract:
The COVID-19 pandemic negatively impacted clinical trial enrollment worldwide, and patient enrollment continues to lag prepandemic levels. The TIMELESS trial (NCT03785678) is a Phase III study to determine whether tenecteplase treatment increases the proportion of good clinical outcomes in patients with acute ischemic stroke who present 4.5-24 hours after symptom onset. The trial has successfully enrolled patients at 〉 90 sites in the US and Canada despite the ongoing pandemic, associated hospital restrictions, and inherent challenges of enrolling patients in an acute stroke trial. The highest-enrolling study sites identified several barriers to patient enrollment and ways to turn obstacles into opportunities to improve the enrollment process. Common themes in patient enrollment failure included insufficient time to complete the consent process, inadequate coordination between departments, and logistic challenges due to hospital restrictions. Solutions included using telemedicine and electronic consent software to rapidly identify patients and provide sufficient time to complete the informed consent process. Software alerts for new stroke cases and HIPAA-compliant messaging applications ensured rapid activation of all staff needed for patient enrollment. Accessible drug storage for rapid dispensing and a comprehensive “step-forward randomization” workflow reduced or eliminated patient enrollment delays caused by study drug retrieval, preparation, and administration. Well-defined roles for the research teams, combined with training and mock enrollment drills, kept research teams engaged and working efficiently within a limited enrollment window. Clear enrollment workflows ensured coordinated responses from multiple departments and could be adapted to changing hospital COVID-19 restrictions. These challenges, while exacerbated by COVID-19, are relevant beyond the pandemic and acute stroke trials. The lessons and experiences of successful sites show that successful clinical trial enrollment requires clear channels of communication, collaboration with nonresearch stakeholders, and an engaged research team with well-defined roles who are committed to integrating research plans into each site’s clinical workflows.
Type of Medium:
Online Resource
ISSN:
0039-2499
,
1524-4628
DOI:
10.1161/str.54.suppl_1.TP30
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2023
detail.hit.zdb_id:
1467823-8
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