The Role of Digital Health Technologies in Drug Development Proceedings of a Workshop (2020) / Chapter Skim
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2 Ethical and Regulatory Considerations for Digital Health Technologies
2 Ethical and Regulatory Considerations for Digital Health Technologies
Pages 5-20
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(Abernethy) • Data generated from DHTs could be used in combination with administrative claims data and electronic health records to build larger and more reliable real-world evidence datas ets.
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Nebeker and Abernethy discussed the categories and uses of DHTs, opportunities to leverage them for capturing real-world evidence, and considerations for moving the field forward in an effective, ethical, and safe manner. CATEGORIES AND USES OF DIGITAL HEALTH TECHNOLOGIES DHTs have provided new tools for researchers to collect data about people's day-to-day activities and can facilitate the study of trial participant behavior in real time by using wearable and remote sensor technologies, mobile applications, and strategies like ecological momentary assessment.1 Nebeker provided an overview of DHTs, such as mobile devices, wearables, and other sensors, that can collect data about participants' everyday lives using these new methods (see Box 2-1)
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. Data management was especially important given that the data would not be included in the electronic health record and therefore not covered by Health Insurance Portability and Accountability Act requirements.
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Although DHTs have value in pre-clinical research, such as for drug discovery and in silico trials, Abernethy focused her remarks on DHT use in pre- and post-market clinical evidence development. Within this broad use of DHTs, Abernethy highlighted three categories: • Data collection support: DHTs, such as biosensors and remote monitoring technologies, can support the collection of study participant–level and operational data, such as information per taining to efficacy and safety endpoints within clinical trials.
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A shift in this direction, she noted, has already begun with the advent of telemedicine as well as with the need to adapt the clinical trial infrastructure in the evolving landscape of coronavirus disease 2019 (COVID-19) .2 Evaluation of Digital Health Technologies for Drug Development "All datasets have warts; we just have to have a way of measuring and solving for data quality," Abernethy said.
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USING DIGITAL HEALTH TECHNOLOGIES TO CAPTURE REAL-WORLD EVIDENCE Abernethy remarked that there is a tendency to associate DHTs with sensors and other wearable technologies. However, the 21st Century Cures Act3 catalyzed an increasing focus on understanding real-world data and evidence, including administrative claims data, EHR data, and data collected from DHTs.
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For example, patient reported outcomes are often missing in the EHR dataset, and clinical variables are missing in administrative claims datasets. Information from biosensors and other digital health solutions could help fill these types of information gaps to build valuable real-world evidence.
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Mistakes may be inevitable when exploring this new digital health frontier, she added, and it will be important to share resulting lessons learned for the entire DHT community to benefit. Engaging Stakeholders in Digital Health Research Nebeker described some of the challenges regarding the various stakeholders in digital health research and how expertise areas could be bridged.
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In contrast, community health workers have less extensive training, but are instrumental partners in bringing research into community settings. Those who are conducting citizen science or participant-led research are unregulated, may have little to no formal research training, and may be unfamiliar with applying the scientific method and research ethics.
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Nebeker and the ReCODE Health team convened a focus group of ethicists, scientists, legal scholars, and regulatory experts to develop a survey that was deployed with behavioral scientists, and the responses were used to identify key domains of ethical principles for digital health: access and usability, privacy, risks and benefits, and data management (see Figure 2-2 for additional details) -- each of which are anchored by the ethical principles of the Belmont Report (Nebeker et al., 2020a)
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Uncertainties Related to Digital Health Technology Use Nebeker outlined several uncertainties related to data management, governance, health care delivery, and informed consent that she believes should be addressed before the use of DHTs in research can move forward. In terms of data management, questions around data ownership, data anonymity, and the use of data de-identification as a potential solution may require more research.
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These uncertainties have prompted Nebeker and ReCODE Health colleagues to conduct studies on an array of considerations in the field of digital health research to bridge the gap between researchers and IRBs on risk assessment, develop a better understanding of concerns about participating in studies using DHTs, and gain further knowledge on terms and conditions participants accept when using DHTs. Nebeker provided further details about each category of research and information gaps to be filled (see Table 2-1)
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In addition to sharing their research results, researchers using digital health technologies also describe how they identified and navigated ethical challenges on the ReCODE Health platform. In many cases, these researchers know more about the potential risks associated with digital health technologies than an IRB.
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She added that social media platforms and other technologies could be used for public outreach and the dissemination of science-based information, with the aim of educating the public while also mitigating hype and misinformation. Regulatory Strategies for Digital Health Technologies Goldsack remarked that the speed of innovation in the DHT space may be escalating at a faster pace than regulatory strategies.
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For example, FDA is collecting 7- to 15-day safety data for investigational new drugs through an application programming interface that directly provides FDA with ready-to-use structured digital information. The third part involves opening up FDA's communication channels to the larger community of DHT innovators and stakeholders so that those stakeholders can understand what kinds of solutions are needed across the life sciences space.
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