Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 665-671 |
| Number of pages | 7 |
| Journal | Journal of Prevention of Alzheimer's Disease |
| Volume | 9 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 2022 |
Bibliographical note
Publisher Copyright:© 2022, Serdi.
Funding
The Alzheimer’s Clinical Trial Consortium (ACTC), funded by the National Institute on Aging, is the leading academic organization in the United States supporting the design and conduct of clinical trials across the AD continuum (, ). The ACTC sponsors innovative clinical trials to support pharmacological and non-pharmacological clinical interventions for prevention and treatment of AD and ADRD conditions. The ACTC partners with 35 leading academic institutions (ACTC sites) throughout the United States to implement this research. ACTC sites adapted to COVID-19 calls for safety and social distancing according to their state and university requirements; adaptation to COVID-19 varied by site and by region throughout the country, as COVID-19 infection rates advanced or receded throughout 2020–2022. The heterogeneity of these adaptations by study site and by region may have long-term implications for ADRD clinical trial research design and findings. Several authors of this manuscript (Drs. Aisen, Grill, Rentz, Petersen, Sperling, Salloway, and Raman) disclose membership on the Executive Leadership Committee of the Alzheimer’s Clinical Trial Consortium. Drs. Rhodus and Pierce have no disclosures. Participating investigators and staff: Dr. David Weidman, Roma Patel, (Banner Alzheimer’s Institute); Dr. Alireza Atri, Carolyn Liebsack (Banner Sun Health Research Institute); Dr. Gad Marshall, Dr. Seth Gale (Brigham and Women’s Hospital); William Menard (Butler Hospital Memory and Aging Center); Dr. Karen Bell, Ruth Tejeda (Columbia University); Lauren Perrey-Moore (Indiana University); Dr. Paul Rosenberg, Samantha Horn (Johns Hopkins University); Dr. Neill Graff-Radford, Anton Thomas (Mayo Clinic, Jacksonville); Dr. Mary Sano, Dr. Maria Loizos, Allison Ardolino (Mount Sinai School of Medicine); Dr. Jacobo Mintzer (Roper St. Francis Research and Innovation Center); Dr. Neelum Aggarwal, Jamie Plenge (Rush University Medical Center); Dr. Sharon Sha, Amanda Ng (Stanford University); Dr. David Sultzer and Shirley Sirivong (UC Irvine); Dr. Mary Koestler (UC San Francisco); Dr. David Geldmacher, Princess Carter (University of Alabama Birmingham); Dr. Jeffery Burns, Dr. Ryan Townley, Becky Bothwell (University of Kansas Medical Center); Dr. Gregory Jicha, Heather Nichols (University of Kentucky); Dr. Judith Heidebrink, Jaimie Ziolkowski (University of Michigan); Dr. Sanjeev Vaishnavi, Martha Combs (University of Pennsylvania); Dr. Oscar Lopez, Leslie Dunn (University of Pittsburgh); Dr. Anton Porsteinsson, Susan Salem-Spencer (University of Rochester Medical Center); Dr. Amanda Smith, Melissa Andrade (University of South Florida Byrd Institute); Dr. Elaine Peskind, Anita Ranta (University of Washington); Dr. Trey Bateman, Abigail O’Connell (Wake Forest School of Medicine); Dr. Joy Snider, Sonia Simons (Washington University in St. Louis); Carol Gunnoud (Yale University). Funding: This project was completed in partnership with the Alzheimer’s Clinical Trial Consortium (ACTC) and the Institute on Methods and Protocols for Advancement of Clinical Trials in ADRD (IMPACT-AD). ACTC is funded by a Cooperative Agreement from the National Institute on Aging, National Institutes of Health (ACTC grant (NIH/NIA U24 AG057437, Aisen / Sperling / Petersen, Multi-PI) and IMPACT-AD is funded by: NIA U13AG067696, NIA U24AG057437, and Alzheimer’s Association SG-20-693744 (Multi-PI: Raman/Grill). The first author was funded by: Training in Translational Research in Alzheimer’s and Related Dementias (NIH T32 AG057461) for the duration of this project.
| Funders | Funder number |
|---|---|
| ACTC | |
| Alzheimer’s Clinical Trial Consortium | |
| Butler Hospital Memory | |
| Impact Technologies | U24AG057437, U13AG067696 |
| “Training in Translational Research in Alzheimer’s and Related Dementias (TRIAD | T32 AG057461 |
| William Menard | |
| National Institutes of Health (NIH) | |
| National Institute on Aging | U24 AG057437, P30AG072946 |
| Alzheimer's Association | SG-20-693744 |
| Yale University | |
| University of Southern Indiana | |
| The George Washington University | |
| The Johns Hopkins University | |
| University of Rochester Medical Center |
Keywords
- Alzheimer’s disease
- Clinical trials
- COVID-19
- research management
ASJC Scopus subject areas
- Clinical Neurology
- Psychiatry and Mental health
