Digital Health Technologies for Medical Devices – Real World Evidence Collection – Challenges and Solutions Towards Clinical Evidence

Abstract

The need for sufficient clinical evidence and the collection of real-world evidence (RWE) is at the forefront of medical device and drug regulations, however, the collection of clinical data can be a time consuming and costly process. The advancement of Digital Health Technologies (DHTs) is transforming the way health data can be collected, analysed, and shared, presenting an opportunity for the implementation of DHTs in clinical research to aid with obtaining clinical evidence, particularly RWE. DHTs can provide a more efficient and timely way of collecting numerous types of clinical data (e.g., physiological, and behavioural data) and can be beneficial with regards to participant recruitment, data management and cost reduction. Recent guidelines and regulations on the use of RWE within regulatory decision-making processes opens the door for the wider implementation of DHTs. However, challenges and concerns remain regarding the use of DHT (such as data security and privacy). Nevertheless, the implementation of DHT in clinical research presents a promising opportunity for providing meaningful and patient-centred data to aid with regulatory decisions.

Holistic Human-Serving Digitization of Health Care Needs Integrated Automated System-Level Assessment Tools

“…Currently, this is generally through ad hoc approaches like investigator-initiated studies and other forms of clinical investigations. These often use validated surveys completed by patients and HCPs that can be implemented directly in the DHT, allowing seamless data collection as these are often networked devices with a user interface (UI) [ 27 ]. Validated survey instruments, including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinician-reported outcomes (CROs) and clinician-reported experience measures (CREMs) serve as standardized, questionnaire-based self-reporting instruments [ 27 ].…”

“…These often use validated surveys completed by patients and HCPs that can be implemented directly in the DHT, allowing seamless data collection as these are often networked devices with a user interface (UI) [ 27 ]. Validated survey instruments, including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs), as well as clinician-reported outcomes (CROs) and clinician-reported experience measures (CREMs) serve as standardized, questionnaire-based self-reporting instruments [ 27 ]. The data generated by these measures are used by clinicians and other health care administrators to evaluate the effectiveness, appropriateness, and acceptability of the investigated therapy and identify areas for QI.…”

Use of Real-World Evidence for International Regulatory Decision Making in Medical Devices

“…During the last 2 decades, there has been a significant shift towards the use of real-world evidence (RWE) to reinforce the pool of evidence for medical products aiming for marketing authorization and regulatory reimbursement. Health Technology Assessment (HTA) organizations have been pioneers in the embracement of RWE, mainly using RWE for descriptive analyses (e.g., treatment patterns), collection and interpretation of epidemiologic data, and monitoring the safety of marketed medical products [1][2][3][4]. Despite this, competent authorities and decision makers still greatly rely on conventional evidence collected from randomized controlled trials (RCTs) (see Figure 1) [1,4].…”