key: cord-0910203-tk5t4lg2
authors: Tom, MeeLee; Cohen, Elisabeth J.; LopezJimenez, Carlos; Hochman, Judith S.; Troxel, Andrea B.; Jeng, Bennie H.
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)()
date: 2021-11-16
journal: Contemp Clin Trials Commun
DOI: 10.1016/j.conctc.2021.100875
sha: d0fd150d17d8e3f9087632f37cb00255dbf72a35
doc_id: 910203
cord_uid: tk5t4lg2

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.

The PCCs all remained committed to the study and none withdrew their participation during the 193 period of this report. Activities at academic and community-based PCCs were similar, and any 194 differences seen were likely related to the regional level of COVID-19 infection. to the success of current and future trials. Missed 0 (0%) 1 (2%) 0 (0%) 1 (2%) 0 (0%) 3 (5%)

J o u r n a l P r e -p r o o f

The Zoster Eye Disease Study (ZEDS): 228 Rationale and design

Adapting to a Pandemic -Conducting Oncology Trials 230 during the SARS-CoV-2 Pandemic

Early Impact 233 of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for 234 Transformation: Findings From an

It is 237 unprecedented: trial management during the COVID-19 pandemic and beyond

Managing clinical trials 240 during COVID-19: experience from a clinical research facility

Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by 242

February 2020 14 9March 2020 9 14April 2020 3 1May 2020 3 5June 2020 13 4July 2020 13 8August 2020 8 4September 2020 19 13October 2020 12 10November 2020 14 16December 2020 10 10January 2021 14 7 

☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.☐The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:J o u r n a l P r e -p r o o f