Faculty, Staff and Student Publications
Language
English
Publication Date
1-1-2023
Journal
PLoS One
DOI
10.1371/journal.pone.0293874
PMID
38011138
PMCID
PMC10681164
PubMedCentral® Posted Date
11-27-2023
PubMedCentral® Full Text Version
Post-print
Abstract
Exercise clinical trials are complex, logistically burdensome, and require a well-coordinated multi-disciplinary approach. Challenges include managing, curating, and reporting on many disparate information sources, while remaining responsive to a variety of stakeholders. The Combined Exercise Trial (COMET, NCT04848038) is a one-year comparison of three exercise modalities delivered in the community. Target enrollment is 280 individuals over 4 years. To support rigorous execution of COMET, the study team has developed a suite of scripts and dashboards to assist study stakeholders in each of their various functions. The result is a highly automated study system that preserves rigor, increases communication, and reduces staff burden. This manuscript describes system considerations and the COMET approach to data management and use, with a goal of encouraging further development and adaptation by other study teams in various fields.
Keywords
Humans, Communication, Exercise
Published Open-Access
yes
Recommended Citation
Clutton, Jonathan; Montgomery, Robert Neal; Mudaranthakam, Dinesh Pal; et al., "An Open-Source System for Efficient Clinical Trial Support: The Comet Study Experience" (2023). Faculty, Staff and Student Publications. 1550.
https://digitalcommons.library.tmc.edu/uthsph_docs/1550