An open-source system for efficient clinical trial support: The COMET study experience.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2023
2023
Historique:
received:
24
05
2023
accepted:
05
10
2023
medline:
29
11
2023
pubmed:
27
11
2023
entrez:
27
11
2023
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 38011138
doi: 10.1371/journal.pone.0293874
pii: PONE-D-23-14868
pmc: PMC10681164
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0293874Subventions
Organisme : NIA NIH HHS
ID : K01 AG072034
Pays : United States
Organisme : NIA NIH HHS
ID : P30 AG072973
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG070036
Pays : United States
Informations de copyright
Copyright: © 2023 Clutton et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Déclaration de conflit d'intérêts
The authors have declared that no competing interests exist.
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