Feasibility of a Noninterventional Decentralized Clinical Trial Model in Adults with Major Depressive Disorder

Abstract

Objective: 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). Methods: 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 realtime data availability). Safety analyses included incidence of adverse events and suicidality. Results: 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. Conclusions: This study demonstrated that decentralized clinical trials can be performed in patients with stable MDD. Clinical trial registration number: None; this was a noninterventional trial.

Clinical research nurse utilisation and role in the conduct of decentralised clinical trials: a literature review

“…Thakur and Lahiry (2021) pointed to the design and structure of the protocol as foundational, encouraging investigators to have community-based operations in mind when selecting endpoints and procedures. This includes the consideration of healthcare professional licensures and scope of practice, which may vary between states and countries (Fowler et al, 2021: 1–11). Geographical distance and under-resourced communities will affect staff availability, prompting trial sponsors to budget additional funds to leverage home health nursing or other professionals to support trial visit completion either in-person or via telehealth (Hawking, 2021; Roberts et al, 2022).…”

“…Geographical distance and under-resourced communities will affect staff availability, prompting trial sponsors to budget additional funds to leverage home health nursing or other professionals to support trial visit completion either in-person or via telehealth (Hawking, 2021; Roberts et al, 2022). The participant experience is also affected, as some feedback has included missing in-person interaction if more virtual components are used in the DCT model (Fowler et al, 2021). Specimens and investigational drugs requiring specific storage and temperature conditions may be at-risk of integrity issues if shipping vendors operate infrequent schedules given increased distance from larger population centres (Anderson, 2021: 1195–1203; Van Norman, 2021: 384–387).…”