Advances in Biomedical Analytics: Real-World Evidence, Digital Health, Robotics and Artificial Intelligence

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biosignal Processing".

Deadline for manuscript submissions: 30 April 2025 | Viewed by 6035

Special Issue Editors


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Guest Editor
Global Medical Analytics, Real-World Evidence, and Health Economics & Outcomes Research, Viatris Inc., Canonsburg, PA 15317, USA
Interests: real-world data; real-world evidence; digital; digital health; artificial intelligence

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Guest Editor
Duke University School of Medicine, Durham, NC 27710, USA
Interests: bioinformatics; precision medicine; survival analysis; genomics; clinical trials

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Guest Editor
Carevive, North Miami, FL 33181, USA
Interests: real-world data; real-world evidence; oncology; health technologies

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Guest Editor
Health and Medical Research Institute, National Institute of Advanced Industrial Science and Technology (AIST), Tsukuba 305-8567, Japan
Interests: robotics; medical devices; regulatory science; bioengineering; electrical engineering

Special Issue Information

Dear Colleague,

Following the 21st Century Cures Act in the United States (US), real-world evidence (RWE) has been well defined. According to the US Food and Drug Administration, real-world data (RWD) are “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”. RWE is “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD”. RWD can be from a variety of sources, such as “data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status”.

With the great emphasis on RWD and RWE has come a variety of challenges and novel ways to optimize and enhance patient-centricity in the development of new therapeutics, whether by informing target selection, designing randomized controlled trials (RCTs), or enabling personalized medicine. This includes novel ways to evaluate disease burden and patient heterogeneity, increased ability to access, generate and leverage fit-for-purpose data sources, and opportunities to harness cloud computing for enhanced scalability and interactivity of digital tools.  This includes novel means of gathering data, such as decentralized RCT’s to facilitate broader patient access, electronic patient-reported outcomes (PROs) capture, digital wearables, and bring-your-own-device (BYOD) designs. With this increase in volume and variety of patient-centric data also come increasing opportunities to adopt and deploy artificial intelligence (AI), machine learning (ML), deep learning (DL), digital health, robotics, and medical devices to unlock novel and timely insights.

This Special Issue focuses on the latest advancements in RWE, digital innovation and AI to enable and improve health care.

Dr. Kelly H. Zou
Dr. Susan Halabi
Dr. Aaron Galaznik
Dr. Kiyoyuki Chinzei
Guest Editors

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Keywords

  • real-world data
  • real-world evidence
  • big data
  • randomized controlled trials
  • patient-reported outcomes
  • digital innovation
  • digital health
  • robotics
  • medical devices
  • artificial intelligence
  • machine learning
  • deep learning

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Published Papers (2 papers)

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15 pages, 1856 KiB  
Article
Remote Symptom Alerts and Patient-Reported Outcomes (PROS) in Real-World Breast Cancer Practice: Innovative Data to Derive Symptom Burden and Quality of Life
by Emelly Rusli, Debra Wujcik and Aaron Galaznik
Bioengineering 2024, 11(8), 846; https://doi.org/10.3390/bioengineering11080846 - 19 Aug 2024
Cited by 2 | Viewed by 1586
Abstract
Treatment for breast cancer (BC) can lead to debilitating symptoms that can reduce outcomes and quality of life (QoL). Symptom surveillance using a remote symptom monitoring (RSM) platform enables the capture and reporting of patient-reported outcomes (PROs) from home. Women with BC used [...] Read more.
Treatment for breast cancer (BC) can lead to debilitating symptoms that can reduce outcomes and quality of life (QoL). Symptom surveillance using a remote symptom monitoring (RSM) platform enables the capture and reporting of patient-reported outcomes (PROs) from home. Women with BC used an RSM platform to complete weekly surveys and report any symptoms experienced during treatment. Symptoms reported as moderate/severe generated alerts to the clinical team. Clinical actions in response to the alert were captured. Results highlighted the value of data generated from a PRO-generated alert system to characterize longitudinal symptom burden and QoL in real-world BC practice, particularly in patients with poor functional status. The most prevalent symptoms that resulted in alerts were pain, nausea/vomiting, neuropathy, fatigue, and constipation. Most women reported one or more moderate/severe symptoms that generated an alert with an average of two alerts per week. Patients with frail status had more alerts, worse QoL and higher treatment bother, indicating that frail patients may benefit from continuous monitoring of symptoms, function, and QoL over time. A case study of patients without pre-existing peripheral neuropathy showed the rapid trajectory from the first report of mild neuropathy until alerts were generated, making a case for early intervention. Full article
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10 pages, 343 KiB  
Perspective
Real-World Data and Real-World Evidence in Healthcare in the United States and Europe Union
by Kelly H. Zou and Marc L. Berger
Bioengineering 2024, 11(8), 784; https://doi.org/10.3390/bioengineering11080784 - 2 Aug 2024
Cited by 1 | Viewed by 2836
Abstract
The use of real-world data (RWD) for healthcare decision-making is complicated by concerns regarding whether RWD is fit-for-purpose or is of sufficient validity to support the creation of credible RWE. An efficient mechanism for screening the quality of RWD is needed as regulatory [...] Read more.
The use of real-world data (RWD) for healthcare decision-making is complicated by concerns regarding whether RWD is fit-for-purpose or is of sufficient validity to support the creation of credible RWE. An efficient mechanism for screening the quality of RWD is needed as regulatory agencies begin to use real-world evidence (RWE) to inform decisions about treatment effectiveness and safety. First, we provide an overview of RWD and RWE. Data quality frameworks (DQFs) in the US and EU were examined, including their dimensions and subdimensions. There is some convergence of the conceptual DQFs on specific assessment criteria. Second, we describe a list of screening criteria for assessing the quality of RWD sources. The curation and analysis of RWD will continue to evolve in light of developments in digital health and artificial intelligence (AI). In conclusion, this paper provides a perspective on the utilization of RWD and RWE in healthcare decision-making. It covers the types and uses of RWD, data quality frameworks (DQFs), regulatory landscapes, and the potential impact of RWE, as well as the challenges and opportunities for the greater leveraging of RWD to create credible RWE. Full article
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