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In the last decade, large technology companies have started many initiatives to stimulate and innovate in the sphere of medical research. A prominent example is the ResearchKit software framework launched by tech giant Apple in 2015. This software framework enables medical researchers to develop research apps on the iPhone that collect and access diverse types of research data. The 'sphere transgressions' theoretical lens (Sharon, 2021a; 2021b) draws attention to the risks associated with such initiatives. For instance, that large technology companies could utilize the initiatives to change the sphere of medical research in line with their own values and interests. However, the theoretical lens risks portraying a simplistic one-directional understanding of Big Tech colonizing the sphere of medical research. This paper draws attention to medical researchers and their everyday interactions. Based on interviews with medical researchers using Apple's ResearchKit in the Netherlands and the United States, the paper shows that researchers are not passive recipients of Big Tech's initiatives. Instead, they respond to their initiatives in a variety of ways: not simply by welcoming or resisting Apple's ResearchKit, but also by 'making do' using a variety of tactics (de Certeau, 1984). Thinking in terms of tactics, it is argued in the discussion, helps to identify needs and interests that are of crucial importance to researchers and the broader sphere of medical research. These insights can be used to strengthen the sphere of medical research and promote responsible innovation. [ABSTRACT FROM AUTHOR]

BACKGROUND: Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described. METHODS: We assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance. RESULTS: Digitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A click and mortar approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials. CONCLUSION: We offer expert guidance and three click and mortar approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.

As a consequence of the COVID-19 pandemic, the number of decentralized clinical trials, trials conducted in whole or in part at locations other than traditional clinical trial sites, significantly increased. While these trials have the potential advantage of access, participant centricity, convenience, lower costs, and efficiency, they also raise a number of important ethical and practical concerns. Here we focus on a number of those concerns, including participant safety, privacy and confidentiality, remote consent, digital access and proficiency, and trial oversight. Awareness of these ethical complexities will help foster the development of processes and cooperative solutions to promote safe, ethical trials going forward, optimized to decrease burden and increase access for all participants. [ABSTRACT FROM AUTHOR]

In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies. [ABSTRACT FROM AUTHOR]

Traditional clinical research relies on conventional strategies to invite and enroll research participants. However, these strategies often fail to reach potential participants from marginalized communities or that reflect the diversity of the nation, such as race, ethnicity, or geography. As we discuss here, the digital clinical study model sets the stage for improved and equitable participation in biomedical research. [ABSTRACT FROM AUTHOR]

Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described. We assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance. Digitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A "click and mortar" approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials. We offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges. [ABSTRACT FROM AUTHOR]

Clinical trials are critically necessary for evaluating new medical drugs, devices, and other interventions designed to improve health. Digital methods have the potential to dramatically reduce the time and expense involved in clinical research, though they also pose new challenges for investigators. The Eureka Research Platform was developed as a national resource for digitizing and mobilizing health research. Platforms like Eureka enable innovation in trial design and methods, enabling remote recruitment strategies, mobile health data collection through connected devices and apps, geofencing for event ascertainment and location-based data collection, ecological momentary assessments, and intervention delivery. Here we describe our cumulative Eureka experience across more than 50 studies launched to date and offer perspectives on emerging opportunities. [ABSTRACT FROM AUTHOR]

During the COVID-19 pandemic, digital strategies and decentralized approaches allowed for the continuation of weight loss clinical trials despite in-person engagement coming to a halt. In particular, trials leveraged remote mediums to measure data in real-time across a broad array of metrics while testing novel strategies to streamline patient care. Such approaches may address longstanding challenges with traditional trials, including attrition and underrepresentation of racial and ethnic minorities. Ultimately, emerging data from trials utilizing both digital and in-person strategies may indicate the promise of a hybrid approach in incorporating a robust virtual component for continuous patient monitoring and an in-person component for patient adherence and data standardization. In this commentary, we provide an overview of the most innovative digital approaches in clinical trials of weight loss during the COVID-19 era, as well as identify opportunities and challenges for these modes of research going forward. [ABSTRACT FROM AUTHOR]

Coronavirus Disease 2019 (COVID-19) has presented an unprecedented challenge for delivering clinical research. The use of technology-assisted data collection for clinical research is desirable for many practitioners, but the acceptability of use in the general population has not been assessed. The aim of the study was to assess attitudes towards using technology-assisted remote methods in the delivery of clinical research in the UK and to understand the barriers to taking part in research with respect to both remote assessments and traditional research methods across different age ranges. The study was conducted as an online anonymous survey with a 4-part questionnaire, between August 2020 and December 2020. Participants living in the UK aged 18 years and above were eligible to take part. A total 351 completed the survey and are included in the data analysis. In all age groups, participants identified that use of online assignments, video calls and telephone calls would make them more likely to take part in clinical research. Overall, the largest barrier to taking part in research was time commitments and timing of the appointment. COVID-19 has had a small, positive influence on the confidence of using technology in the general population. The study found that there is a large interest in taking part in research using online, telephone and video call appointments, which could facilitate research delivery in light of ongoing COVID-19-related restrictions and also improve the accessibility and inclusivity of research. [ABSTRACT FROM AUTHOR]

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators., Competing Interests: The authors have no conflicting interests to disclose., (© 2020 Published by Elsevier Inc.)