key: cord-0799783-wbuyhog2 authors: Bardach, Shoshana H.; Gibson, Allison K.; Rhodus, Elizabeth K.; Jicha, Gregory A. title: Will “social distancing” lead to future “research distancing”: A reflection on COVID‐19 impacts on Alzheimer's disease research date: 2020-08-03 journal: Alzheimers Dement (N Y) DOI: 10.1002/trc2.12045 sha: 98ea6f2ab28957363f62aa55ba7228396fce56bb doc_id: 799783 cord_uid: wbuyhog2 Coronavirus disease 19 (COVID‐19) has dramatically altered everyday life, including the field of Alzheimer's disease (AD) research. This perspective article explores some of the ways in which COVID‐19 has already impacted the field, anticipates some of the long‐lasting effects, and explores strategies for addressing current and future needs. Areas of impact include study integrity, regulatory and industry issues, and participant engagement. Proposed strategies for addressing these challenges include analytic methods to deal with large degrees of missing data and development of patient‐centered, user‐friendly, remote data collection tools and assessments. We also highlight the importance of maintaining participant well‐being as a first and constant priority. Coronavirus disease 19 (COVID-19) has dramatically altered everyday life, including the field of Alzheimer's disease (AD) research. This perspective article explores some of the ways in which COVID-19 has already impacted the field, anticipates some of the long-lasting effects, and explores strategies for addressing current and future needs. Areas of impact include study integrity, regulatory and industry issues, and participant engagement. Proposed strategies for addressing these challenges include analytic methods to deal with large degrees of missing data and development of patient-centered, user-friendly, remote data collection tools and assessments. We also highlight the importance of maintaining participant well-being as a first and constant priority. The immediate impact of COVID-19 includes analytic challenges with ongoing studies that, due to requirements for social distancing, will now have inconsistent adherence to protocols as designed with visit schedules and medication and intervention adherence all more fluid than in ideal circumstances. 3 Addressing this challenge will require skilled statisticians using available, and perhaps novel, analytic methods to ensure that we do not incorrectly conclude that a new treatment is ineffective due to midstream pauses and interruption of drug dosing. Alzheimer's Dement. 2020;6:e12045. wileyonlinelibrary.com/journal/trc2 1 of 3 https://doi.org/10.1002/trc2.12045 Although we are all still reeling from the rapid onset of this crisis, we also need to consider the possibility that higher than anticipated study attrition may lead to failed trials. It remains unclear, but of critical importance, how will regulatory agencies consider the data stemming from AD trials interrupted by COVID-19. In the United States, the U.S. Food and Drug Administration (FDA) has issued statements of assurance that they understand the need for study interruptions and protocol deviations, but how they will resolve the impact of such study conduct on future regulatory decisions remains unknown. Given these considerations, industry sponsors are currently weighing the cost/risk/benefit ratios of continuing ongoing studies or simply halting trials altogether and beginning anew once the crisis has abated. We have encountered mixed feelings among participants; some are vol- After we move past the most acute period of COVID-19, the effects on AD clinical research will persist. Because the need for remote data collection has been clearly demonstrated, we anticipate an increased investment in the development of remote tools and assessments that will enable gathering of clinical and neuropsychological data from the participant's home. This is a welcome move toward increased participant-centeredness. This transition, however, will be accompanied by additional challenges to ensure that we do not exacerbate existing health disparities by leaving those without access to technology, which may be required for remote monitoring activities, behind. We believe the field can rise to meet the current challenges, transforming the need for social distancing into an impetus for positive change. These potential beneficial changes in trial design, statistical methodologies to address even large swaths of missing data, changes in regulatory rules and oversight, and the development of new tools for remote assessment of cognition and decline are critical priorities for the field. These areas provide a real opportunity for constructive change in the face of what is otherwise a devastating crisis. While responding to and anticipating these challenges, we need to keep our participants at the forefront of our thoughts. Demonstrating that protecting participants is a priority will go a long way to building and maintaining trust in research. In contrast, if we put research needs above participant health we will have significant distrust to overcome in the future. Our efforts today can dramatically improve the clinical trial landscape as we move forward. Epidemiology and clinical features of COVID-19: a review of current literature Alzheimer's Disease research enterprise in the era of COVID-19/SARS-CoV-2. Alzheimer's Dement Does social distancing matter? University of Chicago, Becker Friedman Institute for Economics Working Paper COVID-19 exacerbating inequalities in the US