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Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
Sylvia Baedorf Kassis1,2, Weidong Lu3, Sarah A White1,2
1Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA.
BMC Complementary Medicine and Therapies
|June 17, 2022
Summary
A self-monitoring toolkit effectively supported data quality and regulatory compliance in a multinational breast cancer clinical trial. This approach ensured consistent review and engagement for study teams.
Area of Science:
- Integrative Medicine
- Oncology
- Clinical Research Methodology
Background:
- A multinational trial investigated acupuncture for hot flashes in breast cancer patients on endocrine therapy.
- No central oversight necessitated a self-monitoring toolkit for data quality and regulatory compliance.
Purpose of the Study:
- To assess the effectiveness of a site performance self-monitoring toolkit in a coordinated multinational clinical trial.
- To support study teams in maintaining high-quality regulatory information and data.
Main Methods:
- Developed a toolkit including a regulatory binder, checklists for study start-up, conduct, and close-out.
- Implemented regular virtual meetings and periodic external remote reviews for accountability.
Main Results:
- Sites in China and South Korea fully completed and submitted the self-monitoring toolkit materials.
- External reviews identified categories of findings, with feedback provided through reports and virtual meetings.
Conclusions:
- Site self-monitoring is a feasible and effective method for quality assessment in minimal risk research.
- This approach can augment formal monitoring in higher-risk studies, driving compliance and engagement.
