Table 2:

Twelve Important Actions to Enhance Enrollment and Trial Completion in Acute Stroke Trials

Actions	Specific tasks and timelines
Study Design
Expansion of eligibility criteria whenever possible to enhance recruitment and generalizability of the trial results	Should be implemented in ongoing and all future studies
Simplification and incorporation of study design into standard workflow as much as possible	Should be implemented in all future studies
Study design that allows co-enrollment in other studies, particularly studies without another intervention.	Encouraged but must always be considered in light of the burden to participating patients, their families and study personnel.
Trial Infrastructure and Start-up
Use of feasibility assessments to determine required number of sites. This process should include clinical databases such as “Get-with-the Guidelines” in the U.S. to determine numbers of eligible patients at participating sites.	Should be implemented in all future studies
Financial support for rapid trial start-up at study sites	Should be implemented in all future studies
Demonstration of clinical (e.g., certified comprehensive stroke centers) and research infrastructure (member of a national stroke research network) and prior successful trial enrollment.	Discussion with certifying agencies in U.S. or equivalent entities in other countries and leadership from national stroke research networks.
Global trials when more than 50 sites required and consider global trials to enhance enrollment even for smaller numbers of sites.	Strongly encouraged at beginning of all larger Phase III trials.
Training cadre of new clinical research professionals for acute stroke trials.	Establishment of funded training cores in national stroke networks.
Enrollment of Participants
Enhancing and streamlining start-up for emergency consent in the U.S. and exploration of emergency consent in those countries not currently using this approach.	Future US conference regarding Emergency Consent for all relevant parties including FDA and open to global participants. Centralization of EFIC workload as much as possible and use of national data in conjunction with local community events.
Financial support for investigator enrollment of eligible participants outside of business hours by all sponsors in all countries.	Can be implemented now in all ongoing acute stroke trials by all sponsors.
Training of investigators in how to enroll participants via telemedicine.	National and regional workshops.
Technology (artificial intelligence) to identify potential eligible participants in prehospital and emergency department settings and rapid notification of study teams.	Already ongoing but needs greater distribution and improved processes.