Alzheimer's Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer's Clinical Trial Consortium Sites

Background The COVID-19 pandemic created challenges in clinical research operations that required immediate and lasting changes. Ojbectives The purpose of this study was to explore adaptations to clinical trial research due to COVID-19 and develop a theoretical framework of emergent strategies related to pandemic mitigation in a national network of Alzheimer's disease clinical trial sites. Design This qualitative study used a grounded theory approach including semi-structured interviews, constant comparative methods, and multi-level, iterative coding. Participants Twenty-six member sites of the Alzheimer's Clinical Trial Consortium participated with a total of 49 participants. Results Findings demonstrate processes of adaptation following COVID-19 onset including establishing safety as priority, focus on scientific preservation, accommodations (creating policies, leadership mindset, maintaining operations, and determining research procedures), and evaluation of changes throughout the course of the pandemic. Communication and maintaining integrity were vital throughout these processes. Conclusion Processes of accommodation among clinical research sites during the pandemic provide critical insights and direction for future clinical trials development and emergent methods in Alzheimer's disease and other therapeutic areas.

Automated summary

This study examines the adaptations to clinical trial research due to COVID-19 and develops a theoretical framework of emergent strategies in a national network of Alzheimer's disease clinical trial sites. The findings highlight the importance of safety, scientific preservation, accommodations, and evaluation of changes during the pandemic. Communication and maintaining integrity are crucial throughout these processes.