The Role of Digital Health Technologies in Drug Development

2020 ◽  
Author(s):  
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Keyword(s):  
Drug Development ◽  
Digital Health ◽  
Health Technologies

Digital health technology enhances resilient behaviour: evidence from the ward

2019 ◽  
Vol 40 (1) ◽  
pp. 34-67 ◽  
Author(s):  
Iacopo Rubbio ◽  
Manfredi Bruccoleri ◽  
Astrid Pietrosi ◽  
Barbara Ragonese
Keyword(s):  
Patient Safety ◽  
Dynamic Capabilities ◽  
Digital Health ◽  
Digital Technologies ◽  
Healthcare Management ◽  
Content Type ◽  
Health Technologies ◽  
Management Domain ◽  
Operational Failure

PurposeIn the healthcare management domain, there is a lack of knowledge concerning the role of resilience practices in improving patient safety. The purpose of this paper is to understand the capabilities that enable healthcare resilience and how digital technologies can support these capabilities.Design/methodology/approachWithin- and cross-case research methodology was used to study resilience mechanisms and capabilities in healthcare and to understand how digital health technologies impact healthcare resilience. The authors analyze data from two Italian hospitals through the lens of the operational failure literature and anchor the findings to the theory of dynamic capabilities.FindingsFive different dynamic capabilities emerged as crucial for managing operational failure. Furthermore, in relation to these capabilities, medical, organizational and patient-related knowledge surfaced as major enablers. Finally, the findings allowed the authors to better explain the role of knowledge in healthcare resilience and how digital technologies boost this role.Practical implicationsWhen trying to promote a culture of patient safety, the research suggests healthcare managers should focus on promoting and enhancing resilience capabilities. Furthermore, when evaluating the role of digital technologies, healthcare managers should consider their importance in enabling these dynamic capabilities.Originality/valueAlthough operations management (OM) research points to resilience as a crucial behavior in the supply chain, this is the first research that investigates the concept of resilience in healthcare systems from an OM perspective, with only a few authors having studied similar concepts, such as “workaround” practices.

scholarly journals Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

2021 ◽  
pp. 191-205
Author(s):  
Michelle Crouthamel ◽  
Robert J. Mather ◽  
Suraj Ramachandran ◽  
Kai Bode ◽  
Godhuli Chatterjee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Drug Development ◽  
Sleep Disturbances ◽  
Digital Health ◽  
The Novel ◽  
Tool Selection ◽  
Health Technologies ◽  
Study Approach ◽  
Digital Medicine ◽  
Regulatory Strategy

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.

Evolution of Digital Technologies and Use of Virtual Assistants in Drug Development

2019 ◽  
pp. 1-20
Author(s):  
Manu Venugopal
Keyword(s):  
Drug Development ◽  
Digital Health ◽  
Critical Role ◽  
Life Sciences ◽  
Digital Technologies ◽  
Development Phase ◽  
Health Technologies ◽  
Daunting Task ◽  
The World

The drug development phase is one of the most time-consuming and expensive stages in the lifecycle of a drug. Marred by patent expirations, price regulations, complexities in disease conditions, life sciences companies are facing a daunting task to bring new molecular entities into the market. Digital health technologies are playing a critical role in addressing some of the challenges faced during drug development. In this chapter, the author talks about the challenges and key trends in the world of drug development, use of new digital health technologies, and the future of drug development. As an example, the author dives into a specific case study on the use of virtual assistants in clinical trials and the benefits of its usage on patients, healthcare professionals, and life sciences companies.

Understanding Decision Making in the Adoption of Digital Health Technology: The Role of Behavioural Economics’ Prospect Theory (Preprint)

2021 ◽  
Author(s):  
Waqas Ullah Khan ◽  
Aviv Shachak ◽  
Emily Seto
Keyword(s):  
Decision Making ◽  
Prospect Theory ◽  
Digital Health ◽  
Health Technology ◽  
Behavioural Economics ◽  
Individual Level ◽  
Health Technologies ◽  
Research Article ◽  
The Individual

UNSTRUCTURED The decision to accept or reject new digital health technologies remains an ongoing discussion. Over the past few decades, interest in understanding the choice to adopt technology has led to the development of numerous theories and models. In 1979, however, psychologists Kahneman and Tversky published their seminal research article that has pioneered the field of behavioural economics. They named their model the “prospect theory” and used it to explain decision making behaviours under conditions of risk and uncertainty as well as to provide an understanding of why individuals may make irrational or inconsistent decisions. Although the prospect theory has been used to explain decision making in economics, law, political science, and clinically at the individual level, its application to understanding choice in the adoption of digital health technology has not been explored.

scholarly journals COVID-19, digital health technology and the politics of the unprecedented

2021 ◽  
Vol 8 (1) ◽  
pp. 205395172110194
Author(s):  
Dillon Wamsley ◽  
Benjamin Chin-Yee
Keyword(s):  
Public Health ◽  
Science And Technology Studies ◽  
Digital Health ◽  
Health Technologies ◽  
Current State ◽  
Global Pandemic ◽  
Public Health Institutions ◽  
Political Economic ◽  
State Responses

The COVID-19 global pandemic has stretched the capacities of public health institutions and health systems around the world, opening the door to a range of technologically-driven solutions. In this article, we seek to historicize the expanding role of digital health technologies and examine the political-economic context from which they have emerged. Drawing on critical insights from science and technology studies, we maintain that the rise of digital health technologies has been catalyzed by broad shifts in global health governance that have expanded the role of market forces in public health and a unique set of political and economic crises that have accelerated the adoption of digital technologies—often under the guise of appeals to technological innovation to address “unprecedented” crises. These interrelated historical trends, we contend, are critical for understanding current state responses to the pandemic and possibilities for more equitable and democratic applications of technology in public health.

Understanding Decision Making in the Adoption of Digital Health Technology: The Role of Behavioural Economics’ Prospect Theory (Preprint)

2021 ◽  
Author(s):  
Waqas Ullah Khan ◽  
Aviv Shachak ◽  
Emily Seto
Keyword(s):  
Decision Making ◽  
Prospect Theory ◽  
Digital Health ◽  
Health Technology ◽  
Behavioural Economics ◽  
Valuable Insight ◽  
Individual Level ◽  
Health Technologies ◽  
The Individual

UNSTRUCTURED The decision to accept or reject new digital health technologies remains an ongoing discussion. Over the past few decades, interest in understanding the choice to adopt technology has led to the development of numerous theories and models. In 1979, however, psychologists Kahneman and Tversky published their seminal research article that has pioneered the field of behavioural economics. They named their model the “prospect theory” and used it to explain decision making behaviours under conditions of risk and uncertainty as well as to provide an understanding of why individuals may make irrational or inconsistent decisions. Although the prospect theory has been used to explain decision making in economics, law, political science, and clinically at the individual level, its application to understanding choice in the adoption of digital health technology has not been explored. Herein, we discuss how the prospect theory can provide valuable insight on why healthcare patients/clients, technology companies, and policymakers may decide to accept or reject digital health technologies.

Reimagining digital health education: Reflections on the possibilities of the storyboarding method

2019 ◽  
Vol 78 (6) ◽  
pp. 633-646 ◽  
Author(s):  
Deborah Lupton ◽  
Deana Leahy
Keyword(s):  
Health Education ◽  
Research Method ◽  
Design Research ◽  
Design Method ◽  
Digital Health ◽  
Health Behaviours ◽  
Health Technologies ◽  
Sociotechnical Imaginaries ◽  
Health Device

Objectives: To use the design method of storyboarding to challenge pre-service health education teachers to work together to think creatively and differently about digital health, to introduce pre-service teachers to the method as a pedagogical technique for use in their own classrooms, to experiment with our methods as a design sociology research project and to analyse the materials generated by the participants. Design: Storyboarding, a design research method for engagement and research that invites participants to generate a narrative using images and words, was used. Setting: We conducted a 3-hour workshop using storyboarding as part of an Australian university programme for pre-service health education teachers. Method: Following an introduction to the sociology of digital health and the possibilities of design methods, the pre-service teachers were formed into groups. Each group was provided with guidelines for imagining a new digital health device. They worked in their groups to generate a narrative in a storyboard format that described how this device would be used as part of everyday life. The groups then presented their storyboard to the class. The storyboards provided the research materials for analysing the sociotechnical imaginaries concerning digital health they presented. Results: We found that the storyboarding method worked well as an engaging and creative exercise for the participants and to generate insights for us as researchers on the ways in which they conceptualised and imagined the role of digital health technologies. However, despite attempts to educate the pre-service teachers in critical thinking in the lead-up to the workshop that emphasised the sociocultural and political contexts of health behaviours, their storyboards largely presented visions of digital health technologies that relied on individualistic behaviour change. Conclusion: After reflecting on the process, our conclusions provide some ideas for the way forward in using storyboarding as a transformative pedagogical and research tool.

scholarly journals Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

2020 ◽  
Vol 4 (1) ◽  
pp. 28-49
Author(s):  
Diane Stephenson ◽  
Robert Alexander ◽  
Varun Aggarwal ◽  
Reham Badawy ◽  
Lisa Bain ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Parkinson Disease ◽  
Critical Path ◽  
Digital Health ◽  
Clinical Manifestations ◽  
Signs And Symptoms ◽  
Sensor Data ◽  
Regulatory Agencies ◽  
Health Technologies

Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

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