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

Abstract: 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 that 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 andoperational barriers. The aim of this thesis is to assess the recent wearable technologies that generate Real World Data and to understand the potential of this data to transform Nordic healthcare industry. A systematic review of clinical trials involving wearable patient monitoring technique in North America, Nordic Countries and other European countries was conducted. 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 of diseases and modify disease progression by real time monitoring of data and develop precision medicine. thus, it is concluded that 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.