Abstract
Objectives
The COVID-19 pandemic has created significant obstacles for clinical trials and human subject research. This paper discusses the challenges our study team encountered while implementing an eHealth intervention during the pandemic, including: increased dropout, cancellation and rescheduling rates, increased mailing returns and delays, social distancing impediments, COVID-19 positive team members, and restricted training access.
Study design
This is a short paper on research protocol for a six-month randomized controlled single-blind trial.
Methods
N/A.
Results
In response to these challenges, we changed the study protocol. We included multimodal communication models, amplified recruitment efforts, expanded our population’s age range, increasingly utilized tracking labels, utilized external space for extra participants, and transitioned to a virtual RA training format.
Conclusions
Sharing our experience and the adaptations required to run a clinical trial during the pandemic should provide useful and practical knowledge for institutions, funding agencies, and researchers. We believe that the lessons learned here would be applicable to future clinical trial research after the pandemic as well.
【저자키워드】 COVID-19, clinical trial, Research protocol, Human subject study, 【초록키워드】 pandemic, Trial, Study protocol, social distancing, knowledge, COVID-19 pandemic, Intervention, Randomized, Research, age, recruitment, Participants, subject, single-blind, positive, objective, researchers, Result, amplified, required, changed, increasingly, transitioned, 【제목키워드】 Randomized controlled trial, running,