Authors and Affiliations: Michael J. Fath, PhD; Gerald L. Klein, MD; Yvonne Elizabeth Otieno: MedSurgPI, Research Triangle Park, NC 27709
Abstract
Background: Clinical trials conducted with traditional methods encounter numerous obstacles, such as problems with patient recruitment and retention, high expenses, and insufficient participant diversity. RPM addresses these clinical trial challenges by combining wireless technology with real-time data collection and minimizing geographic participation barriers.
Objectives: This review examines the effects of wireless RPM technologies on decentralized and hybrid clinical trials. It examines the improvements that RPM can make as well as the regulatory requirements for this type of technology.
Methods: We identified implementation strategies, technological frameworks, and outcomes of RPM in clinical trials found in recent publications and case studies. We identified common challenges in traditional trials and evaluate RPM solutions across diverse therapeutic areas, device types, and implementation contexts using a systematic approach to data extraction, quality assessment, and comparative outcome analysis.
Results: The deployment of RPM systems has yielded substantial benefits, as demonstrated by better participant recruitment and retention rates, increased diversity and data quality, and decreased costs. Case studies demonstrated lower readmission rates, decreased emergency visits, and healthcare costs while achieving better participant compliance. Implemented programs produced diversity improvements between 15 and 28%, maintained participant retention between 85 and 91%, and achieved cost savings of $2,000 to $2,300 per person. The implementation of RPM systems achieved a 60-85% reduction in recall bias and a 60% decrease in manual data entry errors while enhancing data completeness by 40-85% compared to traditional methods.
Conclusion: Remote patient monitoring delivers a practical way of conducting clinical trials that complies with regulatory standards and improves trial efficiency, quality, and participant experience. By implementing RPM technologies, clinical research can achieve a more economical and patient-focused study structure.