ABSTRACT
The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) is a large, federally funded neurology clinical trial network that was established in 2011. At the start of the COVID-19 pandemic, five clinical studies were active in the network. Rapid response to the evolving COVID-19 situation was critical as clinical study staff transitioned to remote work and on-site research activities were limited. During this session, we will discuss the impacts of the global pandemic on the active clinical trials in the NeuroNEXT network. The ongoing clinical trials were in various stages of study start-up, participant follow-up, and study closeout. Each study required investigators to develop solutions that were simple, yet flexible, all while maintaining study integrity and patient safety. We will highlight the specific adjustments made to the trials and summarize strategies to be carried forward to future studies. The structure of our session will be five presentations covering the following topics: 1. Introduction of NeuroNEXT and the Active Clinical Trials (Brenda Thornell, BS;∼8 min): • Overview of NeuroNEXT Network Structure. • Overview of status of the NeuroNEXT Network (NN) trials impacted by COVID. • Identification of COVID impact. 2. Site Communication and Monitoring (David Klements, MS, CCRP & Michele Costigan, RN, BSN, CCRC;;14 min): • Drafting guidance to study sites for implementation of protocol modifications. • Tracking local restrictions and guidelines by each site and geographic region. • Regular meetings/teleconferences with sites to discuss challenges and potential solutions with conducting study activities during the pandemic. • Remote monitoring. • Drug accountability-dispensing, compliance, and returns. 3. Protocol Changes and Data Collection (Trevis Huff, BSE;∼13 min): • Capturing National Institutes of Health/Food and Drug Administration requested COVID-19 impact data. • Allowing for and tracking telehealth/remote visits. • Accommodating Drug Dispensing/Shipping/ Receiving challenges 4. Reporting on COVID Study Impacts (Elizabeth Klingner, MS and Anna Gudjonsdottir, MS;;11 min): • COVID related protocol deviations and adverse events. • Recruitment and retention before and after the pandemic. • Data quality. • Analysis implications 5. Lessons Learned and Recommendations (Janel Fedler, PhD;;4 min): • Adjustments that maintain trial integrity and patient safety. • Documentation and communication. • Design and conduct of future trials. • Following the presentations, there will be a 10-min Q&A.