Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov 27;18(11):e0293874.
doi: 10.1371/journal.pone.0293874. eCollection 2023.

An open-source system for efficient clinical trial support: The COMET study experience

Jonathan Clutton  1 , Robert Neal Montgomery  1 , Dinesh Pal Mudaranthakam  1 , Erin M Blocker  2 , Ashley R Shaw  1 , Amanda N Szabo Reed  1 , Eric D Vidoni  1
Affiliations

An open-source system for efficient clinical trial support: The COMET study experience

Jonathan Clutton et al. PLoS One. .

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.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Data flow.
Fig 2
Fig 2. Stakeholder information flow.
See this image and copyright information in PMC

References

    1. Kramer AF, Hahn S, Cohen NJ, Banich MT, McAuley E, Harrison CR, et al. Ageing, fitness and neurocognitive function. Nature. 1999;400: 418–419. doi: 10.1038/22682 - DOI - PubMed
    1. Kramer AF, Colcombe S. Fitness Effects on the Cognitive Function of Older Adults: A Meta-Analytic Study—Revisited. Perspect Psychol Sci. 2018;13: 213–217. doi: 10.1177/1745691617707316 - DOI - PubMed
    1. Gu MO, Conn VS. Meta-analysis of the effects of exercise interventions on functional status in older adults. Res Nurs Health. 2008;31: 594–603. doi: 10.1002/nur.20290 - DOI - PubMed
    1. Chodzko-Zajko WJ P D Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009/06/12 ed. 2009;41: 1510–1530. - PubMed
    1. Snowden M, Steinman L, Mochan K, Grodstein F, Prohaska TR, Thurman DJ, et al. Effect of Exercise on Cognitive Performance in Community-Dwelling Older Adults: Review of Intervention Trials and Recommendations for Public Health Practice and Research. J Am Geriatr Soc. 2011;59: 704–716. doi: 10.1111/j.1532-5415.2011.03323.x - DOI - PubMed