Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)

Purpose: To describe steps taken that enabled a high rate of retention and early resumption of enrollment in the Zoster Eye Disease Study (ZEDS), a randomized controlled trial funded by the National Eye Institute, during the first 13 months (3/1/2020–3/31/2021) of the COVID–19 pandemic. Methods: A n...

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Autores principales:	MeeLee Tom, Elisabeth J. Cohen, Carlos LopezJimenez, Judith S. Hochman, Andrea B. Troxel, Bennie H. Jeng
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Retention Enrollment Clinical trial COVID-19 pandemic Zoster Eye Disease Study Herpes zoster ophthalmicus Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/a96e9cb1ebe84e4f8b3436cf3f183e2c
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spelling	oai:doaj.org-article:a96e9cb1ebe84e4f8b3436cf3f183e2c2021-11-26T04:36:33ZMeeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)2451-865410.1016/j.conctc.2021.100875https://doaj.org/article/a96e9cb1ebe84e4f8b3436cf3f183e2c2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001757https://doaj.org/toc/2451-8654Purpose: To describe steps taken that enabled a high rate of retention and early resumption of enrollment in the Zoster Eye Disease Study (ZEDS), a randomized controlled trial funded by the National Eye Institute, during the first 13 months (3/1/2020–3/31/2021) of the COVID–19 pandemic. Methods: A number of responses were implemented in ZEDS when the focus shifted to retention of study participants at the beginning of the pandemic including frequent communication with the participating clinical centers (PCCs) about remote visits, local lab work, shipping study medication, and completion of revised case report forms. Additional payments were provided to the PCCs. Remote activation of PCCs continued. Screening and enrollment visits gradually resumed when allowed. Results: Communication with PCCs increased, and average attendance at monthly coordinator teleconferences went up from 17 to 47. Remote visits peaked in April 2020, accounting for 75% (33/44) of study visits, then declined to less than 10% of study visits beginning August 2020. Overall, 97% (590/609) of study visits were completed. Only 5.5% (9/165) of study participants withdrew consent, and 2.4% (4/165) were lost to follow-up. Enrollment returned to pre-pandemic levels by September 2020. Discussion: Strong communication and unwavering commitment, combined with the technological capability for remote work, visits, and shipment of study medication, were key to the successful retention of study participants and resumption of enrollment. Conclusions: Rapid responses to challenges to trials caused by the COVID-19 pandemic can enable them to continue successfully and provide insights into the planning of future trials.MeeLee TomElisabeth J. CohenCarlos LopezJimenezJudith S. HochmanAndrea B. TroxelBennie H. JengElsevierarticleRetentionEnrollmentClinical trialCOVID-19 pandemicZoster Eye Disease StudyHerpes zoster ophthalmicusMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100875- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Retention Enrollment Clinical trial COVID-19 pandemic Zoster Eye Disease Study Herpes zoster ophthalmicus Medicine (General) R5-920
spellingShingle	Retention Enrollment Clinical trial COVID-19 pandemic Zoster Eye Disease Study Herpes zoster ophthalmicus Medicine (General) R5-920 MeeLee Tom Elisabeth J. Cohen Carlos LopezJimenez Judith S. Hochman Andrea B. Troxel Bennie H. Jeng Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
description	Purpose: To describe steps taken that enabled a high rate of retention and early resumption of enrollment in the Zoster Eye Disease Study (ZEDS), a randomized controlled trial funded by the National Eye Institute, during the first 13 months (3/1/2020–3/31/2021) of the COVID–19 pandemic. Methods: A number of responses were implemented in ZEDS when the focus shifted to retention of study participants at the beginning of the pandemic including frequent communication with the participating clinical centers (PCCs) about remote visits, local lab work, shipping study medication, and completion of revised case report forms. Additional payments were provided to the PCCs. Remote activation of PCCs continued. Screening and enrollment visits gradually resumed when allowed. Results: Communication with PCCs increased, and average attendance at monthly coordinator teleconferences went up from 17 to 47. Remote visits peaked in April 2020, accounting for 75% (33/44) of study visits, then declined to less than 10% of study visits beginning August 2020. Overall, 97% (590/609) of study visits were completed. Only 5.5% (9/165) of study participants withdrew consent, and 2.4% (4/165) were lost to follow-up. Enrollment returned to pre-pandemic levels by September 2020. Discussion: Strong communication and unwavering commitment, combined with the technological capability for remote work, visits, and shipment of study medication, were key to the successful retention of study participants and resumption of enrollment. Conclusions: Rapid responses to challenges to trials caused by the COVID-19 pandemic can enable them to continue successfully and provide insights into the planning of future trials.
format	article
author	MeeLee Tom Elisabeth J. Cohen Carlos LopezJimenez Judith S. Hochman Andrea B. Troxel Bennie H. Jeng
author_facet	MeeLee Tom Elisabeth J. Cohen Carlos LopezJimenez Judith S. Hochman Andrea B. Troxel Bennie H. Jeng
author_sort	MeeLee Tom
title	Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
title_short	Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
title_full	Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
title_fullStr	Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
title_full_unstemmed	Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)
title_sort	meeting the challenges of retention and enrollment of study participants in clinical trials during the covid-19 pandemic from the study leadership perspective: experience from the zoster eye disease study (zeds)
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/a96e9cb1ebe84e4f8b3436cf3f183e2c
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Meeting the challenges of retention and enrollment of study participants in clinical trials during the COVID-19 pandemic from the study leadership perspective: Experience from the Zoster Eye Disease Study (ZEDS)

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