Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium

Byrom, Bill; Watson, Christopher; Doll, Helen; Coons, Stephen Joel; Eremenco, Sonya; Ballinger, Rachel; Carthy, Marie Mc; Crescioni, Mabel; O’Donohoe, Paul; Howry, Cindy

doi:10.1016/j.jval.2017.09.012

Cited by 63 publications

(51 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…If mobile data gathering technologies were proven to be at least as meaningful as the current “gold standards” used in clinical trials, widespread use of these tools might, among other things, encourage greater patient participation in clinical research (due to fewer site visits), reduce the costs of conducting studies, and enable sponsors to gather more data to generate evidence about treatment performance in real-world settings [5, 6]. …”

Section: Introductionmentioning

confidence: 99%

A Pilot Study to Assess the Feasibility of Collecting and Transmitting Clinical Trial Data with Mobile Technologies

et al. 2018

View full text Add to dashboard Cite

Background: The use of mobile technologies for data capture and transmission has the potential to streamline clinical trials, but researchers lack methods for collecting, processing, and interpreting data from these tools. Objectives: To assess the performance of a technical platform for collecting and transmitting data from six mobile technologies in the clinic and at home, to apply methods for comparing them to clinical standard devices, and to measure their usability, including how willing subjects were to use them on a regular basis. Methods: In part 1 of the study, conducted over 3 weeks in the clinic, we tested two device pairs (mobile vs. clinical standard blood pressure monitor and mobile vs. clinical standard spirometer) on 25 healthy volunteers. In part 2 of the study, conducted over 3 days both in the clinic and at home, we tested the same two device pairs as in part 1, plus four additional pairs (mobile vs. clinical standard pulse oximeter, glucose meter, weight scale, and activity monitor), on 22 healthy volunteers. Results: Data collection reliability was 98.1% in part 1 of the study and 95.8% in part 2 (the percentages exclude the wearable activity monitor, which collects data continuously). In part 1, 20 of 1,049 overall expected measurements were missing (1.9%), and in part 2, 45 of 1,083 were missing (4.2%). The most common reason for missing data was a single malfunctioning spirometer (13 of 20 total missed readings) in part 1, and that the subject did not take the measurement (22 of 45 total missed readings) in part 2. Also in part 2, a higher proportion of at-home measurements than in-clinic readings were missing (12.6 vs. 2.7%). The data from this experimental study were unable to establish repeatability or agreement for every mobile technology; only the pulse oximeter demonstrated repeatability, and only the weight scale demonstrated agreement with the clinical standard device. Most mobile technologies received high “willingness to use” ratings from the patients on the questionnaires. Conclusions: This study demonstrated that the wireless data transmission and processing platform was dependable. It also identified three critical areas of study for advancing the use of mobile technologies in clinical research: (1) if a mobile technology captures more than one type of endpoint (such as blood pressure and pulse), repeatability and agreement may need to be established for each endpoint to be included in a clinical trial; (2) researchers need to develop criteria for excluding invalid device readings (to be identified by algorithms in real time) for the population studied using ranges based on accumulated subject data and established norms; and (3) careful examination of a mobile technology’s performance (reliability, repeatability, and agreement with accepted reference devices) during pilot testing is essential, even for medical devices approved by regulators.

show abstract

Section: Introductionmentioning

confidence: 99%

A Pilot Study to Assess the Feasibility of Collecting and Transmitting Clinical Trial Data with Mobile Technologies

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Some initial recommendations have been published. [39][40][41][42] However, these recommendations are not yet comprehensive and will continue to mature with increasing use of PT. As such, an updated review of the specific regulations, policies, and gaps affecting the use of PT is warranted, and should be the subject of future work.…”

Section: Engage With Regulators In Trial Design Goal Setting and Stmentioning

confidence: 99%

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

Polhemus¹,

Kadhim

Barnes

et al. 2019

Ther Innov Regul Sci

View full text Add to dashboard Cite

Background: Patient-facing digital technologies (also called "Patient Technology" [PT]) have the potential to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized. Methods: In order to understand the factors affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts, including pharmaceutical company representatives, clinical trial investigators at a number of trial sites worldwide, and clinical trial participants. All interview and survey responses were blinded and aggregated by a third-party consultant and themes were extracted. Results: There was general consensus around the potential value of patient-facing technology as a clinical research tool, though a variety of challenges faced by each stakeholder were discussed. Detailed accounts of opportunities (improved patient experience, compliance, and engagement; clinical trial efficiencies; improved data quality and insights) and barriers (organizational and corporate cultural challenges, business-related challenges, user willingness and burden, and regulatory challenges) are reported. Conclusions: While the barriers to PT adoption explored here were numerous, they were also generally consistent. A number of proposals for establishing more holistic, collaborative, and strategic approaches to PT implementation in clinical trials are discussed. Such approaches could facilitate more effective, widespread adoption of PT, and thereby a more patient-centric clinical trial paradigm.

show abstract

“…A sensor is a device or device component that detects and measures physical or chemical information from a surrounding physical environment, and translates this into an electrical output signal . Microsensors are miniature sensors that have electrical and mechanical operation components, also termed microelectromechanical systems (MEMS).…”

Section: Wearable and Mobile Applicationsmentioning

confidence: 99%

“…However, in our highly regulated industry, the validity of outcomes data collected using wearable and remote devices, and mHealth applications, must be subject to appropriate levels of rigorous examination. This has recently been comprehensively examined by the Critical Path Institute's Electronic Patient‐Reported Outcome (ePRO) Consortium who have put forward recommendations for the evidence needed to support the selection of a wearable device or remote sensor for use in clinical trials to support labeling claims . We provide a summary of these recommendations later in this article.…”

Section: Application To Clinical Trialsmentioning

confidence: 99%

“…An endpoint description includes information defining how and when they are measured, how they are calculated, rules for missing data, and how they are analyzed. In the absence of formal regulatory guidance, the Critical Path Institute's ePRO Consortium reported consensus recommendations on the evidence required to support wearable device selection and endpoints derived from wearables data …”

Section: Considerations For Evidence To Support Device Use and Endpoimentioning

confidence: 99%

See 1 more Smart Citation

Brain Monitoring Devices in Neuroscience Clinical Research: The Potential of Remote Monitoring Using Sensors, Wearables, and Mobile Devices

Byrom

Carthy²,

Schueler³

et al. 2018

Clin Pharma and Therapeutics

Self Cite

View full text Add to dashboard Cite

The increasing miniaturization and affordability of sensors and circuitry has led to the current level of innovation in the area of wearable and microsensor solutions for health monitoring. This facilitates the development of solutions that can be used to measure complex health outcomes in nonspecialist and remote settings. In this article, we review a number of innovations related to brain monitoring including portable and wearable solutions to directly measure brain electrical activity, and solutions measuring aspects related to brain function such as sleep patterns, gait, cognition, voice acoustics, and gaze analysis. Despite the need for more scientific validation work, we conclude that there is enough understanding of how to implement these approaches as exploratory tools that may provide additional valuable insights due to the rich and frequent data they produce, to justify their inclusion in clinical study protocols.

show abstract

Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium

Abstract: Using this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance.

Cited by 63 publications

References 19 publications

A Pilot Study to Assess the Feasibility of Collecting and Transmitting Clinical Trial Data with Mobile Technologies

A Pilot Study to Assess the Feasibility of Collecting and Transmitting Clinical Trial Data with Mobile Technologies

Accelerating Adoption of Patient-Facing Technologies in Clinical Trials: A Pharmaceutical Industry Perspective on Opportunities and Challenges

Brain Monitoring Devices in Neuroscience Clinical Research: The Potential of Remote Monitoring Using Sensors, Wearables, and Mobile Devices

Contact Info

Product

Resources

About