key: cord-0914806-aila65jf
authors: Lowenhaupt, Stephanie; Molloy, Angela
title: Virtual coordinator and site training and reorganization of a multisite consortium upon grant renewal: Challenges of the NeuroNEXT network
date: 2021-07-26
journal: Contemp Clin Trials Commun
DOI: 10.1016/j.conctc.2021.100821
sha: 42724f0f86c3e0b198d835dc60b7ec2ecdba3021
doc_id: 914806
cord_uid: aila65jf

The COVID-19 pandemic abruptly forced changes in how to conduct multicenter clinical research. Gone were the days of face-to-face meetings and working together in person. Virtual teams became the norm rather than exception. The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT: NN) was created with a vision to conduct studies in neurological diseases through partnership with academia, private foundations and industry. 1 A fundamental aspect of the establishment and maintenance of this network was and is the NeuroNEXT virtual coordinator network. We found ourselves well-prepared for methods required of the pandemic because of our prior experience.

The COVID-19 pandemic abruptly forced changes in how to conduct multicenter clinical research. Gone were the days of face-to-face meetings and working together in person. Virtual teams became the norm rather than exception.

The Network for Excellence in Neuroscience Clinical Trials (Neu-roNEXT: NN) was created with a vision to conduct studies in neurological diseases through partnership with academia, private foundations and industry [1] . A fundamental aspect of the establishment and maintenance of this network was and is the NeuroNEXT virtual coordinator network. We found ourselves well-prepared for methods required of the pandemic because of our prior experience.

We describe the methodology of activities of the Coordinators' Committee of NeuroNEXT in the sometimes-stressful transition of grant renewal and treatment center changeover. We present the methodology of our virtual orientation system and, in Results, measurements of its effectiveness. We share our experiences with the NeuroNEXT Network so that other networks and consortia may be able to benefit from the coordinator education team's experiences.

The Network consists of a Clinical Coordinating Center (CCC) at Massachusetts General Hospital, a Data Coordinating Center (DCC) at the University of Iowa, and 25 funded clinical sites chosen based on ge-ographic location and a history of strength in conducting neurological clinical trials ( Table 1 ). The network was funded in 2011 by the National Institute of Neurological Disease and Stroke (NINDS) for Phase II clinical trials. Funding supports 100 % of a chosen clinical research coordinator salary who is responsible for all site operations.

When the network was refunded in 2018, nearly one-third of sites were replaced. It was critical for the network's success that all the Neu-roNEXT Coordinators at each site collaborate to incorporate the new sites. The challenge was to implement a near-seamless start-up for the newly awarded sites and to provide support for all the legacy coordinators while also considering diversity in learning needs, logistics and delivery methods.

The model for incorporation included coordinator training with standardized resources and an innovative, virtual mentorship program. A focus of training was to provide new coordinators the knowledge and resources needed to support and bring aboard the site Principal Investigators into the network as well.

The process began with a literature search of best practices in building and maintaining a virtual team and collaboration science [2, 3] . We further refined our search focusing on articles outlining virtual team structure, functioning, team member engagement and culture within the healthcare or research arena [4] . We conducted discussions among legacy NN coordinators to evaluate shortcomings, needs, and best practices.

From these resources, we adapted these best practices into our training initiatives, including 1) the development of a coordinator specific We anticipated that the coordinator mentorship program would be a critical feature to overcome site isolation and bring new coordinators into the team. A virtual "buddy system", the program paired legacy, veteran coordinators with coordinators from new sites. Mentors and mentees were matched by geographic location and institution structure (multicenter institutions versus single center, full-time versus shared coordinators). Acknowledgement of time zone differences and institutional structures provided for a more optimal virtual learning experience. Important factors that were central to the mentorship process were recognizing the need for personal connection, relationship building and addressing concerns as soon as they were identified.

To aid legacy coordinators, the centralized resources and virtual preparatory meetings enabled "buddies" to provide a consistent network wide training while accounting for the range of mentee experience and individual strengths and weaknesses.

The general resources were reinforced by a regular series of coordinator conferences conducted via teleconferences and webinars with an opportunity for discussion and interaction. A typical agenda included identified topics provided by the coordinators. Interactions were a key component so that communication was not just delivering information to the team.

An evaluation survey was sent to all coordinators 9 months after the training program was launched. The survey was a combination of structured and open questions to solicit more in-depth responses. The structured questions provided an opportunity to establish a profile about the coordinator in the network such as experience, length of time in the network and measuring the effectiveness of the tools that were developed. Open questions provided responses to help the education team with suggestions for improvement and further educational opportunities.

The open comments provided details that supplemented the overall positive feedback returned from the structured survey. A sample from mentees included "Comforting to have an identified experienced person to go to for questions." Mentors comments were "Program helps the mentees feel more like they belong by having someone specific to reach out to as it is often easy to feel lost in a large network", "Program created a dedicated resource to the mentee which is important-decrease turn over, efficiency, continuity and a partnership."

Effectiveness of the program was confirmed by comparison of site productivity metrics. The time needed for site activation and data quality metrics are comparable for the new and original sites. For studies with ongoing recruitment, the rate of new enrollments at the new sites exceeded the rate at the original sites (Study NN107: new = 0.68, orig-inal = 0.18 patients per site; Study NN108: new 0.48 48 original, 0.30 patients per site).

Virtual Teams are challenging to build and maintain due to lack of face-to-face interactions and difficulty bonding. Our success pre-COVID depended on the balance of maintaining centralized resources and leadership balanced against the needs of individuals that varied with experience, site organizational and time zone differences. Key features were developing individual relationships with formal mentorship pairings.

Acknowledging each coordinators experiences, skills and unique qualities they bring to the team is instrumental in building a strong virtual collaboration. An inherent problem in virtual team building is an individual team member may feel anonymous and isolated which may lead to lack of motivation. Getting to know each team member on a personal level and building a sense of trust amongst each other is vital. A successful team dynamic is to include interactions on a personal level, sharing personal stories, as well as working together to get the job done building on each other strengths. In addition, recognizing team members for their accomplishments and successes are important in keeping up morale and motivation [5] .

In the Post-COVID Era, NeuroNEXT was able to pivot quickly to keep the momentum going as we shifted to working from home. Some adaptations needed to be made initially with use of technology to help with signatures for regulatory documents and more utilization of video conferencing, Our virtual team strength continued through the challenging times of COVID-19.

As we move forward in this continually evolving work environment, virtual teams are becoming the standard way to conduct business. We need to seize the opportunity to become successful in this new business model.

Mark Quigg MD MSc (University of Virginia), Merit Cudkowicz, MD MSc (Massachusetts General Hospital), Christopher Coffey PhD (University of Iowa).

The views expressed in the submitted article are our own and not an official position of our institutions or funder.

Authors are supported by NeuroNEXT Grants funded by the National Institute of Neurological Disease and Stroke. University of Virginia U24NS107182 (Quigg) University of Cincinnati 5U24NS107200 (Woo and Glauser) Massachusetts General Hospital U01 NS077179 (Cudkowicz) University of Iowa U01 NS077352 (Coffey).

There is no conflict of interest by any author.

NeuroNEXT Clinical Study Sites, Seven-year experience from the national Institute of neurological disorders and stroke-supported network for excellence in neuroscience clinical trials

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