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4 Digital Health Technologies for Recruitment and Safety
Pages 41-60

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From page 41...
... • Digital health technologies can help surmount traditional research barriers and bring research to the general public through large-scale decentralized trials that collect a broad range of real-world data from participants.
From page 42...
... • Digital health technologies could support a comprehensive system for patient-centered care, in which standardized re mote data collection facilitates clinical research and continu ous learning as well as returning value to patients through better clinical care. (Perakslis)
From page 43...
... Chris Benko, chief executive officer at Koneksa Health, discussed the roles of DHTs and remote monitoring as part of the drug development process during early-stage clinical trials; he shared findings from the company's validation studies to evaluate the use of remote technologies for assessments in early-stage clinical studies. He also suggested some potential uses for digital technologies to address the coronavirus disease 2019 (COVID-19)
From page 44...
... From a regulatory point of view, he said, the most important component is the interpretation of the concept. Beyond simply collecting data, a proposal for a DDT should indicate whether it contributes to improvement for an individual's daily life -- specifically, if the DDT is beneficial to the extent that the change is substantial and of personal value to people, or if the change is so small that it does not improve people's lives to a large extent.
From page 45...
... Regulatory Perspective on Digital Health Technologies as Biomarkers For FDA, a biomarker is a defined characteristic that is measured as an indicator of normal or pathogenic biological processes or as a response to an intervention, Leptak said. In contrast to a COA, a biomarker is not a clinical assessment of how a patient feels, functions, or survives.
From page 46...
... A small subset of biomarkers that are predictive of clinical benefits might become surrogate endpoints, he added. Digital Health Technologies as Biomarkers from a Regulatory Perspective A common question is whether certain DHTs might be considered biomarkers by default or whether they are considered to be another type of drug development tool in addition to COAs and biomarkers, Leptak said.
From page 47...
... Often, they have a more informal engagement with FDA through type B and type C meetings to explain the work.5 Adhering to the right methods is important, Benko said, but in many cases this work does not necessarily need to be oriented around the more well-known validation frameworks. Conceptual Framework for Regulatory Acceptance of Digital Health Technologies in Biomarker Development Leptak discussed a conceptual framework for biomarker development for regulatory acceptance (see Figure 4-1)
From page 48...
... Devoting time to those conversations at the outset can be useful because it allows for learning from negative results in situations in which the trial design or data collection process does not go as predicted. Addressing Unmet Drug Development Needs Proposals for DDTs typically include an explication of the unmet drug development need that will be met by the tool, Leptak said.
From page 49...
... . Overcoming Research Barriers to Digital Health Technologies Clinical studies have been conducted for centuries in a way that is inaccessible for many members of the public, Chan said.
From page 50...
... Despite using a single platform, the Asthma Mobile Health Study was able to reach patients with severe baseline disease -- around 13 percent of participants had a history of intubation, a marker for severe disease. More traditional methodologies would be less likely to reach those patients or others who would be less likely to participate in a study, such as people living outside of large academic hubs and in rural areas.
From page 51...
... Digital Health Technologies to Promote Recruitment and Retention DHTs can promote recruitment and retention in research studies, Chan said. For example, the Asthma Mobile Health Study benefited from the involvement of Apple ResearchKit and its introduction at a large Apple event.
From page 52...
... This can make it difficult to interpret potential safety findings, he added. Digital Health Technologies for Assessments in Early-Stage Clinical Trials Given the disadvantages associated with the reliance on CPUs in early-stage clinical trials, there is growing interest in the potential role of remote technologies for the assessment of pharmacokinetics, pharmaco
From page 53...
... DIGITAL HEALTH TECHNOLOGIES AND THE COVID-19 PANDEMIC In dealing with the COVID-19 pandemic, there are emerging areas of interest related to using DHTs and the remote monitoring of vital signs and potential COVID-19-related symptoms as a proxy for disease incidence prior to confirmation with laboratory testing, Benko said. DHTs such as sensors and digital biomarkers connected to the body could be used to monitor vital signs and symptoms remotely using software; this could be complemented with electronic patient-reported outcomes collected via mobile phones or other devices.
From page 54...
... Shifting conventional clinical assessments into a remote mode could help protect clinical trial participants by reducing the need for participants to visit clinical settings where they could be put at risk, put others at risk, or otherwise place additional burdens on health care systems. For example, pulmonary function tests typically require a person to breathe into a machine during an in-hospital assessment, potentially promoting the spread of disease.
From page 55...
... The results of the study, he said, build confidence in the use of DHTs to capture real-world data on vital signs with sufficient sensitivity to detect the kinds BOX 4-2 Evaluation of Digital Health Technology for Cardiovascular Monitoring An open-label randomized clinical trial was conducted to evaluate a mobile device for cardiovascular monitoring in healthy male volunteers. The first part of the study began with a side-by-side comparison of wearable mHealth devices (the 1-Preventice BodyGuardian® Single Lead ECG and the A&D UA-767PBT-Ci Blood Pressure Monitor)
From page 56...
... Expanding the body of research on functional status in a way that uses DHTs for data collection will require addressing a substantial change-management problem within the oncology therapeutics leadership at many of the major drug development companies. DEPLOYING DIGITAL HEALTH TECHNOLOGIES AT THE INTERSECTION OF CLINICAL CARE AND RESEARCH Eric Perakslis, Rubenstein Fellow, Duke University The use of DHTs should begin with the idea that necessity is the mother of invention, Perakslis said.
From page 57...
... "If you are thinking small, you are not going to trip and fall into big." Those leading the federal-level response to COVID-19 should "think big" in their efforts to address the deep-rooted systemic problems that the pandemic has exposed. Supporting Patients and Ensuring Data Privacy Outside of Traditional Clinical Settings To more effectively incorporate DHTs into clinical care and research, Perakslis suggested working with community health workers (e.g., nurses
From page 58...
... Diagnosis contact info Local Treatment Health Advice Authority Drug & Dx Quarantine +/- test results R&D CDC Data Samples public health Case Symptoms reporting WHO Measures Definition Demographics Contacts NHS Travel digital measures … Location … 6. Communications Layer: Public Service Announcements Clinical Bulletins … FIGURE 4-2 Telehealth-based learning health system during an infectious disease outbreak.
From page 59...
... Ensuring data standards and data validity when collecting data outside of traditional clinical settings requires high-level coordination, standardization, and organization, Perakslis said. During the Ebola outbreak in West Africa, the World Health Organization (WHO)
From page 60...
... Each clinical interaction offers a unique and irreplaceable opportunity to capture information from that patient; the technology to collect data rapidly, securely, and comprehensively is already available and should be employed to its full extent. DISCUSSION Streamlining Regulatory Approval During Crises The pharmaceutical industry, a workshop participant said, is entirely dependent on the rules and regulations established by governing bodies, while other industries have seen a paradigm shift in which consumers and manufacturers are compelling regulators to change more swiftly.


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