Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials

Masanneck, Lars; Gieseler, Pauline; Gordon, William J.; Meuth, Sven G.; Stern, Ariel Dora

doi:10.1038/s41746-023-00767-1

Cited by 40 publications

(30 citation statements)

References 25 publications

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“…In recent years, a growing body of evidence has documented the increasing use of DHTs in clinical trials, both overall and in studies of specific conditions, such as neurological diseases. 2,3 Simultaneously, the emergence of several pre-competitive groups ; Despite increasing regulatory support for the use of DHTs in clinical trials, product development firms remain hesitant to increase DHT use. Efforts to reduce operational barriers and additional regulatory clarity may be needed to realize the patient-centric benefits of DHTs in product development.…”

Section: Tepid Uptake Of Digital Health Technologies In Clinical Tria...mentioning

confidence: 99%

“…[4][5][6] The incorporation of DHTs into clinical trials represents an important step toward achieving more patient-centric therapeutic development. DHTs can be used to capture changes in meaningful aspects of health for patients with chronic conditions (e.g., Parkinson's disease), 3 which has become increasingly important to the FDA in evaluating treatment effects. 7,8 DHTs can also increase participant convenience by enabling decentralized trial designs 9 and, relatedly, can improve the diversity of trial participants by limiting the number of required site visits, reducing the costs of participation, and improving patient satisfaction.…”

Section: Tepid Uptake Of Digital Health Technologies In Clinical Tria...mentioning

confidence: 99%

“…In recent years, a growing body of evidence has documented the increasing use of DHTs in clinical trials, both overall and in studies of specific conditions, such as neurological diseases 2,3 . Simultaneously, the emergence of several pre‐competitive groups advancing DHT use in trials, such as the Digital Medicine Society (DiMe), the Clinical Trials Transformation Initiative (CTTI), and the Scripps Research Digital Trials Center, has piqued the interest of pharmaceutical and medical device firms in using DHTs in product development, as evidenced by reported participation from industry in these initiatives 4–6…”

mentioning

confidence: 99%

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Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

Marra,

Stern

2024

Clin Pharma and Therapeutics

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Digital health technologies (DHTs) can enable more patient‐centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting and structuring patient‐generated data for regulators to use in approval decisions alongside traditional clinical outcomes. Although a growing body of evidence has documented increasing use of DHTs in clinical trials overall, the use of DHTs in clinical trials supporting medical product development is unclear; here, we quantify the use of DHTs in clinical trials sponsored by pharmaceutical and medical device firms. Despite interest from pharmaceutical and medical device manufacturers in DHTs, we find tepid uptake of DHTs in trials by these sponsor types over time. Further, to date, these sponsors have most frequently used conventional, hardware‐based technologies that have been available for many years (e.g., Holter monitors and glucose meters) rather than newer activity monitors, mobile apps, and other online‐based tools that are frequently used by non‐industry sponsors. Considering the recent and evolving nature of regulatory guidance around DHT use in clinical trials, our findings suggest that organizations pursuing product development still appear hesitant to incorporate DHTs in trials that provide the most critical evidence for regulatory review and impact how new products are used. This suggests there are likely additional opportunities for sponsors of regulated trials to incorporate (more) DHTs and patient‐centric endpoints into product development clinical trials. However, additional regulatory clarity and efforts to reduce operational barriers may be needed in order to more fully capture these opportunities.

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Section: Tepid Uptake Of Digital Health Technologies In Clinical Tria...mentioning

confidence: 99%

Section: Tepid Uptake Of Digital Health Technologies In Clinical Tria...mentioning

confidence: 99%

“…In recent years, a growing body of evidence has documented the increasing use of DHTs in clinical trials, both overall and in studies of specific conditions, such as neurological diseases 2,3 . Simultaneously, the emergence of several pre‐competitive groups advancing DHT use in trials, such as the Digital Medicine Society (DiMe), the Clinical Trials Transformation Initiative (CTTI), and the Scripps Research Digital Trials Center, has piqued the interest of pharmaceutical and medical device firms in using DHTs in product development, as evidenced by reported participation from industry in these initiatives 4–6…”

mentioning

confidence: 99%

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Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

Marra,

Stern

2024

Clin Pharma and Therapeutics

Self Cite

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“…Although there is a recent example elsewhere in clinical research using a DHT as a primary clinical endpoint[32], this is not current practice in the ADRD space. However, the growing acceptance of DHTs as secondary endpoints in ADRD research [33,34] is slowly moving the field towards this possibility [35,36].…”

Section: Clinical Researchmentioning

confidence: 99%

Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort

Lott,

Streel,

Bachman

et al. 2024

Preprint

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Digital health technologies offer valuable advantages to dementia researchers and clinicians as screening tools, diagnostic aids, and monitoring instruments. To support the use and advancement of these resources, a comprehensive overview of the current technological landscape is essential. A multi-stakeholder working group, convened by the Digital Medicine Society (DiMe), conducted a landscape review to identify digital health technologies for Alzheimers disease and related dementia populations. We searched studies indexed in PubMed, Embase, and APA PsycInfo to identify manuscripts published between May 2003 to May 2023 reporting analytical validation, clinical validation, or usability/feasibility results for relevant digital health technologies. Additional technologies were identified through community outreach. We collated 172 peer-reviewed manuscripts, poster presentations, or regulatory documents for 106 different technologies for Alzheimers disease and related dementia assessment covering diverse populations such as Lewy Body, vascular dementias, frontotemporal dementias, and all severities of Alzheimers disease. Wearable sensors represent 32% of included technologies, non-wearables 61%, and technologies with components of both account for the remaining 7%. Neurocognition is the most prevalent concept of interest, followed by physical activity and sleep. Clinical validation is reported in 69% of evidence, analytical validation in 34%, and usability/feasibility in 20% (not mutually exclusive). These findings provide a landscape overview for clinicians and researchers to appraise the clinical utility and relative maturity of technologies for assessing Alzheimers disease and related dementias.

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“…The most widely deployed use of digital technologies is in Parkinson's disease (PD). 4 This is perhaps not surprising, as most digital technologies include accelerometers and gyroscopes, enabling the direct assessment of movement and motor function, which are prominent disease signs in PD. However, the early adoption of technology in the field of PD also relates to the limitations of the current clinical assessment.…”

mentioning

confidence: 99%

Digital Mobility Measures: A Window into Real‐World Severity and Progression of Parkinson's Disease

Mirelman,

Volkov,

Salomon

et al. 2023

Movement Disorders

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BackgroundReal‐world monitoring using wearable sensors has enormous potential for assessing disease severity and symptoms among persons with Parkinson's disease (PD). Many distinct features can be extracted, reflecting multiple mobility domains. However, it is unclear which digital measures are related to PD severity and are sensitive to disease progression.ObjectivesThe aim was to identify real‐world mobility measures that reflect PD severity and show discriminant ability and sensitivity to disease progression, compared to the Movement Disorder Society‐Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) scale.MethodsMulticenter real‐world continuous (24/7) digital mobility data from 587 persons with PD and 68 matched healthy controls were collected using an accelerometer adhered to the lower back. Machine learning feature selection and regression algorithms evaluated associations of the digital measures using the MDS‐UPDRS (I–III). Binary logistic regression assessed discriminatory value using controls, and longitudinal observational data from a subgroup (n = 33) evaluated sensitivity to change over time.ResultsDigital measures were only moderately correlated with the MDS‐UPDRS (part II‐r = 0.60 and parts I and III‐r = 0.50). Most associated measures reflected activity quantity and distribution patterns. A model with 14 digital measures accurately distinguished recently diagnosed persons with PD from healthy controls (81.1%, area under the curve: 0.87); digital measures showed larger effect sizes (Cohen's d: [0.19–0.66]), for change over time than any of the MDS‐UPDRS parts (Cohen's d: [0.04–0.12]).ConclusionsReal‐world mobility measures are moderately associated with clinical assessments, suggesting that they capture different aspects of motor capacity and function. Digital mobility measures are sensitive to early‐stage disease and to disease progression, to a larger degree than conventional clinical assessments, demonstrating their utility, primarily for clinical trials but ultimately also for clinical care. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

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Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials

Cited by 40 publications

References 25 publications

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

Digital Health Technologies for Alzheimer’s Disease and Related Dementias: Initial Results from a Landscape Analysis and Community Collaborative Effort

Digital Mobility Measures: A Window into Real‐World Severity and Progression of Parkinson's Disease

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