Digital Clinical Trials for Substance Use Disorders in the Age of Covid-19

Abstract

As a result of the coronavirus 2019 (Covid-19) pandemic, clinical research for substance use disorders (SUDs) has been impeded due to widespread stay-at-home mandates limiting the operations of “non-essential” work. Although appropriate to proceed with an abundance of caution to prevent viral spread, there will be detrimental consequences for patients with SUDs if clinical trials research cannot adapt and continue uninterrupted. The field of digital health has strong evidence for its feasibility and effectiveness and offers tools that can facilitate the continuation of SUD clinical trials research remotely in accordance with Covid-19 precautions. Some digital tools have been used as components of SUD research in the past; however, no published clinical trial in SUDs to-date has been entirely virtual. This has important implications for disrupted clinical care, as providers seek guidelines for best digital practices. This paper provides a roadmap for integrating the fields of digital health and SUD clinical trials by proposing methods to complete recruitment, screening, informed consent, other study procedures, and internal lab operations digitally. The immediate future of SUD research depends on the ability to comply with social distancing. Investment in research of digital clinical trials for SUDs provides an opportunity to cultivate benefits for research and clinical care long-term as we can (1) define regulatory requirements for the implementation of digital systems, (2) develop consensus on system-wide standards and protocols in the appropriate use of technology, and (3) gain experience that can translate to the treatment of patients with SUDs through telehealth in the community.

Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures

“…Some studies describe the use of digital technology in trials prior to the pandemic [16][17][18]. Other sources present a theoretical basis of how digital clinical trials or telehealth-based research may be accomplished based on current clinical uses of digital technology [19][20][21][22]. Here we describe procedural changes with regard to recruitment, screening, data collection, and regulatory study activities in a multicenter clinical trial focused on pediatric rural populations during the COVID-19 global pandemic.…”

Participation of rural patients in clinical trials at a multisite academic medical center

“…The the need for on-site visits, and may increase the access to clinical trials in the rural population in the future. [29][30][31][32] In this study, 221 (76%) trials offered to reimburse expenses and/or remunerate participants. Although financial bonus is welcomed by participants, it is not usually the only reason to participate.…”

“…However, in this study, rural participants were slightly older than urban participants (65 vs 64 years). The COVID-19 pandemic has fostered the utilization of technology-enabled solutions such as digital consent, virtual visits, and collection of data at home, often with remote sensors, which obviate the need for on-site visits, and may increase the access to clinical trials in the rural population in the future [29][30][31][32].…”

Virtual Infection Prevention and Control in Low- and Middle-Income Countries

“…A real-world randomized controlled trial of a web-based training module about personal protective equipment from Switzerland could be implemented in LMICs (Suppan et al, 2020). Theoretical VIPC applications described in the literature include applying AI to radiology images to detect infectious diseases, using robots to disinfect facilities, and using telecommunications to conduct clinical trials (Alwashmi, 2020;Brezing et al, 2020;Khan et al, 2020).…”