Digital health technology derived measures: Biomarkers or clinical outcome assessments?

Izmailova, Elena S.; Demanuele, Charmaine; Carthy, Marie Mc

doi:10.1111/cts.13529

Cited by 6 publications

(6 citation statements)

References 20 publications

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“…18 Interpretation of ClinROs and PROs is further complicated by the fact that they may not be concordant with one another; for example, research has demonstrated that oncologists and nurses are more likely to record greater performance status than patients themselves. 19 In contrast to infrequent "snapshot" assessments of functional status collected through traditional COA methods, digitally enabled COAs and biomarkers 20 offer the opportunity to collect comprehensive and contemporaneous data to assess physical, cognitive, and behavioral function among patients with cancer in order to drive personalized medicine and gain insights into the consequences of anticancer therapies.…”

Section: Traditional Clinical Outcome Assessments Of Functional Statu...mentioning

confidence: 99%

“…In contrast to infrequent “snapshot” assessments of functional status collected through traditional COA methods, digitally enabled COAs and biomarkers 20 offer the opportunity to collect comprehensive and contemporaneous data to assess physical, cognitive, and behavioral function among patients with cancer in order to drive personalized medicine and gain insights into the consequences of anticancer therapies.…”

Section: Traditional Clinical Outcome Assessments Of Functional Statu...mentioning

confidence: 99%

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A proposed multi‐domain, digital model for capturing functional status and health‐related quality of life in oncology

Izmailova,

Wagner,

Bakker

et al. 2024

Clinical Translational Sci

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Whereas traditional oncology clinical trial endpoints remain key for assessing novel treatments, capturing patients' functional status is increasingly recognized as an important aspect for supporting clinical decisions and assessing outcomes in clinical trials. Existing functional status assessments suffer from various limitations, some of which may be addressed by adopting digital health technologies (DHTs) as a means of collecting both objective and self‐reported outcomes. In this mini‐review, we propose a device‐agnostic multi‐domain model for oncology capturing functional status, which includes physical activity data, vital signs, sleep variables, and measures related to health‐related quality of life enabled by connected digital tools. By using DHTs for all aspects of data collection, our proposed model allows for high‐resolution measurement of objective data as patients navigate their daily lives outside of the hospital setting. This is complemented by electronic questionnaires administered at intervals appropriate for each instrument. Preliminary testing and practical considerations to address before adoption are also discussed. Finally, we highlight multi‐institutional pre‐competitive collaborations as a means of successfully transitioning the proposed digitally enabled data collection model from feasibility studies to interventional trials and care management.

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Section: Traditional Clinical Outcome Assessments Of Functional Statu...mentioning

confidence: 99%

Section: Traditional Clinical Outcome Assessments Of Functional Statu...mentioning

confidence: 99%

A proposed multi‐domain, digital model for capturing functional status and health‐related quality of life in oncology

Izmailova,

Wagner,

Bakker

et al. 2024

Clinical Translational Sci

Self Cite

View full text Add to dashboard Cite

show abstract

“…Here, we broadly examine the technology-based challenges facing the use of wearables by care delivery teams or those working in clinical trials within neuroscience. It is worth noting that real-world deployment of wearables in care delivery and clinical trial settings face different regulatory pathways and the reader is directed elsewhere for those topics (Vasudevan et al, 2022 ; Izmailova et al, 2023 ; Leyens et al, 2024 ).…”

Section: Introductionmentioning

confidence: 99%

Considering and understanding developmental and deployment barriers for wearable technologies in neurosciences

Wall,

Celik,

Hetherington

et al. 2024

Front. Neurosci.

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“…Digital measure developers have started adopting this guidance to initiate regulatory submissions amidst discussion of a dedicated pathway for deploying digital measures as drug development tools (DDTs) 23 .…”

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confidence: 99%

Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance

Aryal,

Blankenship,

Bachman

et al. 2024

npj Digit. Med.

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Digital health technologies (DHTs) have the potential to modernize drug development and clinical trial operations by remotely, passively, and continuously collecting ecologically valid evidence that is meaningful to patients’ lived experiences. Such evidence holds potential for all drug development stakeholders, including regulatory agencies, as it will help create a stronger evidentiary link between approval of new therapeutics and the ultimate aim of improving patient lives. However, only a very small number of novel digital measures have matured from exploratory usage into regulatory qualification or efficacy endpoints. This shows that despite the clear potential, actually gaining regulatory agreement that a new measure is both fit-for-purpose and delivers value remains a serious challenge. One of the key stumbling blocks for developers has been the requirement to demonstrate that a digital measure is meaningful to patients. This viewpoint aims to examine the co-evolution of regulatory guidance in the United States (U.S.) and best practice for integration of DHTs into the development of clinical outcome assessments. Contextualizing guidance on meaningfulness within the larger shift towards a patient-centric drug development approach, this paper reviews the U.S. Food and Drug Administration (FDA) guidance and existing literature surrounding the development of meaningful digital measures and patient engagement, including the recent examples of rejections by the FDA that further emphasize patient-centricity in digital measures. Finally, this paper highlights remaining hurdles and provides insights into the established frameworks for development and adoption of digital measures in clinical research.

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Digital health technology derived measures: Biomarkers or clinical outcome assessments?

Cited by 6 publications

References 20 publications

A proposed multi‐domain, digital model for capturing functional status and health‐related quality of life in oncology

A proposed multi‐domain, digital model for capturing functional status and health‐related quality of life in oncology

Considering and understanding developmental and deployment barriers for wearable technologies in neurosciences

Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance

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