Student Thesis
Digitally Enabled, Wearable Remote Patient Monitoring of Clinical Trials to Assess Patient Reported Outcomes-A Systematic Review; Shifting Paradigm from Site-Centric to Patient Centric Health Care
Title: Digitally Enabled, Wearable Remote Patient Monitoring of Clinical Trials to Assess
Patient Reported Outcomes-A Systematic Review
Author: Harsimran Kaur
The faculty: School of Health and Welfare, Halmstad University.
Supervisor’s name: Kristina Zeigert
Examiner’s name: Linus Andersson
Pages: 71 including Appendices
Keywords: Clinical Trials, Digitalisation, Remote Patient Monitoring, Wearable Medical
Devices.
Summary: Although the digital revolution has transformed many niches of human activity,
healthcare sector and pharmaceutical drug development has been relatively slow in embracing
emerging technologies to optimize health efficacy, especially in Nordic Countries. The topic is
of more importance now owing to the present scenario of the corona virus (COVID-19)
outbreak, which has caused unparalleled disruption in the conduct of clinical trials and presented
challenges as well as opportunities for clinical trialists and data analysts. In this master thesis, the
potential opportunity with virtual or digital clinical trials as viable options to enhance drug
development efficiency is highlighted and offers diverse patients easier and attractive ways to
participate in clinical trials. Special reference is made to wearable devices in clinical trial
execution and generating real world data; its acquisition and processing in a virtual trial setting.
Issues of patient safety, measurement reliability and validity, and data privacy & integrity are
reviewed, and considerations are put forward for mitigation of underlying regulatory and
operational barriers.
AIM: To assess the recent wearable technologies that generate Real World Data and to
understand the potential of this data to transform Nordic healthcare industry.
METHOD: A systematic review of clinical trials involving wearable patient monitoring
technique in North America, Nordic Countries and other European countries was conducted.
RESULT: Out of various innovative wearable technologies, Smartwatches are found to be the
most common and it is also observed that these wearable technologies have been able to help in
early detection and diagnosis and modify disease progression by real time monitoring of data and
develop precision medicine.
CONCLUSION: Wearable Remote Patient Monitoring is a novel technique that has few barriers;
but promises a big transformation in Nordic Countries as well as in entire healthcare industry
P003S | Library of Congress | Available |
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