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31 - Best Practices for Clinical Trials during COVID-19

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Saif-Ur-Rahman Paracha ,
William Maurice Redden  and
George Grossberg
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

The COVID-19 pandemic caused enormous disruption of clinical, research, and academic services around the world. This chapter focuses on the impact of COVID-19 on clinical trials and reflects upon the various measures taken to continue research work while minimizing risk to participants. Through careful observations, we conclude that it is imperative to continue Alzheimer’s disease (AD) drug development programs. With proper infection prevention protocols and precautions in place, it is possible to preserve the safety of both study participants, and investigators/research staff while moving forward with essential drug development processes for the benefit of study participants, and patients in general. Such protocols, once perfected, need to become a part of all institutional review boards and study protocols in order to avoid any loss or delay of essential work in the future.

Keywords

COVID-19Alzheimer’s diseaseClinical trialspandemicdementianursing homedrug developmentremote access
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 354 - 360
Publisher: Cambridge University Press
Print publication year: 2022

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References

World Health Organization. WHO mortality database. Available at: www.who.int/healthinfo/mortality_data/en/ (accessed June 1, 2021).Google Scholar
Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391–460.CrossRefGoogle Scholar
Hebert, LE, Weuve, J, Scherr, PA, et al. Alzheimer disease in the United States (2010–2050) estimated using the 2010 Census. Neurology 2013; 80: 1778–83.CrossRefGoogle ScholarPubMed
Lao, K, Ji, N, Zhang, X, et al. Drug development for Alzheimer’s disease: review. J Drug Target 2019; 27: 164–73.CrossRefGoogle ScholarPubMed
Cummings, J, Ritter, A, Zhong, K. Clinical trials for disease-modifying therapies in Alzheimer’s disease: a primer, lessons learned, and a blueprint for the future. J Alzheimers Dis 2018; 64: S3–22.CrossRefGoogle Scholar
Cummings, J, Feldman, HH, Scheltens, P, et al. The “rights” of precision drug development for Alzheimer’s disease. Alzheimers Res Ther 2019; 11: 76.CrossRefGoogle Scholar
Tuttle, KR. Impact of the COVID-19 pandemic on clinical research. Nat Rev Nephrol 2020; 16: 562–4.Google Scholar
Asaad, M, Khan Habibullah, K, Butler, CE, et al. The impact of COVID-19 on clinical trials. Ann Surg 2020; 272: e222–3.Google Scholar
Applied Clinical Trials. Findings from a Tufts study examining the effects of COVID-19 on clinical trials. Available at:www.appliedclinicaltrialsonline.com/view/covid-19-and-its-impact-on-the-future-of-clinical-trial-execution (accessed December 20, 2020).Google Scholar
Sathian, B, Asim, M, Banerjee, I, et al. Impact of COVID-19 on clinical trials and clinical research: a systematic review. Nepal J Epidemiol 2020; 10: 878–87.CrossRefGoogle ScholarPubMed
Food and Drug Administration. FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. March 2020. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency (accessed May 20, 2020).Google Scholar
Medicines and Healthcare products Regulatory Agency Inspectorate. Advice for management of clinical trials in relation to Coronavirus. March 12, 2020. Available at: https://mhrainspectorate.blog.gov.uk/2020/03/12/advice-for-management-of-clinical-trials-in-relation-to-coronavirus/ (accessed June 1, 2021).Google Scholar
European Medicines Agency. Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic. Version 3. April 28, 2020. Available at: https://ecrin.org (accessed June 1, 2021).Google Scholar
Australian Government Agency:Therapeutic goods administration. Clinical trial processes: information relating to COVID-19. March 31, 2020. Available at: www.tga.gov.au/clinical-trial-processes (accessed May 30, 2021).Google Scholar
Comas-Herrera, A, Zalakain, J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. April 12, 2020. Available at: https://ltccovid.org/2020/04/12/mortality-associated-with-covid-19-outbreaks-in-care-homes-early-international-evidence/ (accessed May 30, 2021).Google Scholar
Altieri, M, Santangelo, G. The psychological impact of COVID-19 pandemic and lockdown on caregivers of people with dementia. Am J Geriatr Psychiatry 2021; 29: 27–34.Google Scholar
UsAgainstAlzheimer’s. UsAgainstAlzheimer’s survey on COVID-19 and Alzheimer’s community summary of findings for June 2020 survey (Survey #4). Available at: www.usagainstalzheimers.org/sites/default/files/2020-06/UsA2%20COVID%20Survey%204%20Summary%206.25.20.pdf (accessed June 1, 2021).Google Scholar
Anker, SD, Butler, J, Khan, MS, et al. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J 2020; 41: 2109–17.CrossRefGoogle Scholar
Medidata. COVID-19 and clinical trials: the Medidata perspective. Available at: www.medidata.com/wp-content/uploads/2020/08/COVID19-Response8.0_Clinical-Trials_2020824_v1.pdf (accessed Nov 29, 2020).Google Scholar
Kennedy, M, Helfand, BKI, Gou, RY, et al. Delirium in older patients with COVID-19 presenting to the emergency department. JAMA Netw Open 2020; 3: e2029540.CrossRefGoogle ScholarPubMed
Lai, FH-Y, Yan, EW, Yu, KK, et al. The protective impact of telemedicine on persons with dementia and their caregivers during the COVID-19 pandemic. Am J Geriatr Psychiatry 2020; 28: 1175–84.CrossRefGoogle ScholarPubMed
Saini, KS, de Las Heras, B, de Castro, J, et al. Effect of the COVID-19 pandemic on cancer treatment and research. Lancet Haematol 2020; 7: e432–5.Google Scholar

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