Abstract
<strong>Objective:</strong> Adding to existing challenges in conducting clinical trials, COVID-19 has indefinitely affected modern clinical research. Decentralized clinical trials, using telemedicine and digital technology, may prove critical to the future of clinical development. This type of methodology in psychiatric trials remains largely unexplored; therefore, we evaluated the feasibility and quality of data collection in a randomized, sham-interventional trial using fully decentralized methodology in subjects with major depressive disorder (MDD). <strong>Methods:</strong> This was a four-week, noninterventional, two-cohort, decentralized, clinical trial. Eligible adults had a diagnosis of MDD and were medically stable. Subjects in cohort 1 continued stable antidepressant and antipsychotic treatment and were randomly assigned 1:1 into assisted or unassisted groups (ie, completing assessments at home aided by mobile healthcare providers or alone using study-provided materials, respectively). Subjects in cohort 2 continued stable antidepressant treatment only or with other therapy and could choose assignment to assisted or unassisted groups. Coprimary endpoints were operational effectiveness (assessed by completion rate, subject diversity, time to study start, and subject satisfaction) and data-collection integrity (assessed by subjects’ ability to collect assessments and real-time data availability). Safety analyses included incidence of adverse events and suicidality. <strong>Results:</strong> In cohort 1, 96 subjects were screened with 31 enrolled; in cohort 2, 46 subjects were screened with 26 enrolled. Most subjects (≥81% across study groups and cohorts), and more than 80% of both cohorts, completed all assessments. No major safety concerns were encountered. <strong>Conclusions:</strong> This study demonstrated that decentralized clinical trials can be performed in patients with stable MDD. <strong>Clinical trial registration number:</strong> None; this was a noninterventional trial.
Highlights
Randomized controlled clinical trials are the gold-standard scientific and regulatory approach to gain health authority approval for new therapies or technologies [1]
Additional barriers for subjects include time and costs associated with completing procedures, attending appointments, and traveling or relocating to be near a trial site, which are disproportionately located near urban areas [2, 5, 6]
After receiving a complete trial description, all subjects provided written informed consent using a handwritten signature digitally executed on a computer or tablet
Summary
Randomized controlled clinical trials are the gold-standard scientific and regulatory approach to gain health authority approval for new therapies or technologies [1]. Challenges persist with multisite clinical trials, including failure to reach accrual goals, which can prolong trial timelines and increase study costs [2, 3]. Principal investigators face barriers that contribute to these challenges, including reduced availability to balance clinical practice with research [2], increasingly complex protocol designs [4], and restrictive eligibility criteria [5]. Additional barriers for subjects include time and costs associated with completing procedures, attending appointments, and traveling or relocating to be near a trial site, which are disproportionately located near urban areas [2, 5, 6]. Access to technology may address many of these barriers in clinical trials. Studies in diabetes research suggest that use of telemedicine may remove geographical and transportation barriers, expanding access to more diverse populations [10, 11]. In a 2004 study, Ruskin et al [12] showed that major depressive disorder (MDD) psychometric assessments (e.g., Hamilton Depression Rating Scale score) had equivalent outcomes when
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