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Remote and semi-automated methods to conduct a decentralized randomized clinical trial
Teresa Cafaro1,2,3, Patrick J LaRiccia3,4, Brigid Bandomer3
1Department of Anesthesiology, Cooper University Health Care, Camden, NJ, USA.
Journal of Clinical and Translational Science
|August 2, 2023
Summary
Remote and automated methods enable efficient clinical trial management, improving subject recruitment, adherence, and data completeness. This approach enhances efficiency without compromising safety or quality in research.
Area of Science:
- Clinical research methodology
- Digital health technologies
- Healthcare innovation
Background:
- Clinical trials face challenges in time and personnel resources.
- Remote and automated methods offer potential solutions for efficient trial conduct.
Purpose of the Study:
- To describe the methodology for conducting a randomized clinical trial using remote and automated processes.
- To demonstrate the feasibility and effectiveness of these methods in a real-world setting.
Main Methods:
- A randomized clinical trial model involving healthcare workers was utilized.
- Recruitment, screening, informed consent, and data collection were performed remotely and automated.
- Study product distribution and adherence monitoring were managed via mail and electronic surveys.
Main Results:
- A small team remotely screened 406 subjects and enrolled 299 within 3 months.
- Achieved 87% study product adherence and 98.5% data completeness over 9 months.
- High usability scores (93.8% for participants, 90% for staff) were reported.
Conclusions:
- Remote and automated methods enhance clinical trial efficiency, recruitment, adherence, and data quality.
- These approaches maintain safety and quality standards.
- An XML template is provided to facilitate the design of future remote clinical trials.
Keywords:
RCTREDCapRandomized clinical trialdecentralizedelectronic data captureinternet methodsremote methodsMore Related Videos
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