Table 2 Recommendations for implementation of the REMAP-COVID trial

Leadership engagement

▪ Balancing dual imperatives of immediate patient care and research

▪ Diffuse interests

▪ Engage early

▪ Inclusive and transparent approach

▪ Align institutional and trial goals

▪ Understand and embrace bedside realities

▪ Share vision of REMAP-COVID as groundwork for learning health system development

Trial embedment

• Research procedures can interfere with daily care

• Hospital committee workloads already high

• Embed trial into routine care processes

• Integrate into existing institutional information dissemination, pharmacy, and telemedicine structures

• Embed trial into electronic health record; can start trial using traditional methods

Remote consent and enrollment

• Technological challenges

• Patient familiarity with technology

• Mock enrollments to test remote process

• Engage bedside providers to assist patients as needed

• Leverage institutional videoconferencing tools

• Intermittent competency training of research personnel

Regulatory compliance and oversight

• Multiple parallel regulatory requirements

• Engage local institutional review board (IRB) to partner with the central IRB

• Close contact with US Regional Coordinating Center at UPMC

• Anticipatory management of new trial domains and arms

Modification of traditional trial management procedures

• Communication around frequent adaptive trial updates

• COVID-19 travel restrictions limit in-person monitoring

• Identify and celebrate natural points of progress and contributions from local champions

• Leverage electronic health record to facilitate protocol adherence, adverse event monitoring, screening and enrollment logs, and data collection and export

• Start trial using traditional procedures

• Virtual town hall meetings

Alignment with other COVID-19 studies

• Multiple studies for same patients

• Establish a centralized institutional process to optimize coordination and collaboration