Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites - 21/11/24

Doi : 10.14283/jpad.2022.79

Elizabeth K. Rhodus ^1,^2,^13,^⁎ , P. Aisen ³, J.D. Grill ^4,^5,^6,⁷, D.M. Rentz ^8,⁹, R.C. Petersen ¹⁰, R.A. Sperling ^8,⁹, S.P. Salloway ¹¹, D. Pierce ¹², R. Raman ³

¹ Sanders-Brown Center on Aging, University of Kentucky, Lexington, KY, USA

² Department of Behavioral Science, University of Kentucky, Lexington, KY, USA

³ Alzheimer’s Therapeutic Research Institute, University of Southern California, San Diego, CA, USA

⁴ Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA

⁵ Alzheimer’s Disease Research Center, University of California, Irvine, Irvine, CA, USA

⁶ Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine, CA, USA

⁷ Department of Neurobiology and Behavior, University of California, Irvine, Irvine, CA, USA

⁸ Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

⁹ Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

¹⁰ Department of Neurology, Mayo Clinic, Rochester, MN, USA

¹¹ Butler Hospital, Brown University, Providence, RI, USA

¹² Department of Occupational Science and Occupational Therapy, Eastern Kentucky University, Richmond, KY, USA

¹³ University of Kentucky, College of Medicine, 463 Healthy Kentucky Research Building, 760 Press Avenue, 40536, Lexington, KY, USA

^a Elizabeth.Rhodus@uky.edu Elizabeth.Rhodus@uky.edu

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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.

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Key words : Clinical trials, Alzheimer’s disease, research management, COVID-19

Plan

Introduction

Methods

Participants

Data Collection and Analysis

Data Credibility

Results

Pandemic Onset

Process of Accommodation

Outcome Evaluation

Discussion

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Vol 9 - N° 4

P. 665-671 - octobre 2022 Retour au numéro

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Alzheimer’s Disease Clinical Trial Research Adaptation Following COVID-19 Pandemic Onset: National Sample of Alzheimer’s Clinical Trial Consortium Sites - 21/11/24

Abstract

Background

Ojbectives

Design

Participants

Results

Conclusion

Plan

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