Abstract Details

Title Lessons Learned From the COVID-19 Pandemic and Recommendations for Reducing Non-Compliance in Clinical Research

Topic Practice, Policy, and Ethics

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 448

Objective The objective of this study was to investigate the COVID-19 lockdown’s impact on the rates of non-compliance in NINDS/NIH because of its potential to negatively impact patient safety and data integrity.

Background COVID-19 has caused 226.2 million confirmed cases and 4.6 million deaths globally. Without treatments or vaccines, distancing and lockdowns were recommended. Despite the benefits, little is known about the effects on patient safety and non-compliance in clinical research during current lockdown guidelines.

Design/Methods Non-compliance events from July 2019 to August 2021 were stratified by the date of non-compliance (pre- or post-lockdown enforced March 11^th, 2020). Then, events were described by size, location, and category of protocols and type, primary category, sub-category, and cause of events. Additionally, non-compliance caused by COVID-19 was analyzed to determine common characteristics.

Results Three hundred and ninety-five non-compliance events occurred across 47 protocols with 14,453 total enrolled patients at risk. The overall rate of non-compliance increased significantly from 0.0164 events per patient to 0.0342 events per patient after the lockdown. The number of non-compliance events increased significantly from 79 events to 293 events for onsite protocols. Seventy-six non-compliance events occurred before the lockdown for small-sized protocols, while 152 occurred after. For events caused by COVID-19, 99% were minor deviations, 99% were related to procedural compliance, 65% involved the patient’s study visit not being completed, and 28% involved the patient’s study visit being completed out of timeframe.

Conclusions It is important to understand this pandemic’s implications for the conduct of clinical research. Protocols should be developed with, and actively amended to include, maximum flexibility to capture all safety data, such as enabling broad study visit windows and blood draws in the community, without compromising scientific quality. This recommendation should be considered when changes occur to existing protocols that are outside of the principal investigator’s control.

Authors/Disclosures
Matthew Gooden PRESENTER	Matthew Gooden has nothing to disclose.
Gina Norato	Gina Norato has nothing to disclose.
Sandra Martin (National Institutes of Health)	Sandra Martin has nothing to disclose.
Avindra Nath, MD, MBBS, FAAN (National Institutes of Health)	The institution of Dr. Nath has received research support from National Institutes of Health. The institution of Dr. Nath has received research support from Target ALS. Dr. Nath has received intellectual property interests from a discovery or technology relating to health care.
Lauren Reoma, MD, FAAN (NIH/NINDS)	Dr. Reoma has received research support from NIH. Dr. Reoma has a non-compensated relationship as a Vice Chair with AAN Experimental Neurotherapeutics Section that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Federal Employee with NINDS/NIH that is relevant to AAN interests or activities. Dr. Reoma has a non-compensated relationship as a Member with ASENT Program Committee that is relevant to AAN interests or activities.

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