Impact of the COVID-19 Pandemic on a Clinical Trial: A Quantitative Report on Study Engagement and Strategies.

ABSTRACT:

Introduction

The COVID-19 pandemic impacted clinical research worldwide potentially altering research findings. The study purpose was to measure the effect of the pandemic on recruitment, retention, assessment, and intervention completion rates.

Methods

Enrollment and participation data from a clinical trial evaluating efficacy of a physical therapy intervention for high-risk preterm infants were compared across 3 pandemic periods (February 2019 through November 2021).

Results

Recruitment, retention, assessment, and intervention completion rates were lowest during the peak pandemic period.

Conclusions

In compliance with the Human Subjects Review Board, and for the participants' and staff safety, transition from in-person to telehealth or hybrid visits was requi

SUBMITTER: Brown SE 

PROVIDER: S-EPMC10527461 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature