Remote and semi-automated methods to conduct a decentralized randomized clinical trial.

Introduction: Designing and conducting clinical trials is challenging for some institutions and researchers due to associated time and personnel requirements. We conducted recruitment, screening, informed consent, study product distribution, and data collection remotely. Our objective is to describe how to conduct a randomized clinical trial using remote and automated methods.
Methods: A randomized clinical trial in healthcare workers is used as a model. A random group of workers were invited to participate in the study through email. Following an automated process, interested individuals scheduled consent/screening interviews. Enrollees received study product by mail and surveys via email. Adherence to study product and safety were monitored with survey data review and via real-time safety alerts to study staff.
Results: A staff of 10 remotely screened 406 subjects and enrolled 299 over a 3-month period. Adherence to study product was 87%, and survey data completeness was 98.5% over 9 months. Participants and study staff scored the System Usability Scale 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team of two members, while safety monitoring was conducted by three to four team members. Conception of the trial to study completion was 21 months.
Conclusions: The remote and automated methods produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can improve efficiency without sacrificing safety or quality. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.
Competing Interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support by a grant from the Won Sook Chung Foundation; PJL and BB are employed full-time by the Won Sook Chung Foundation. TLB and KQN are employed part-time by the Won Sook Chung Foundation. TC, HG, DT, and MAM were employed part-time by the Won Sook Chung Foundation during the study. TC holds the position of research coordinator at Cooper University Health Care; this position is fully funded by the Won Sook Chung Foundation. The president of the Won Sook Chung Foundation, MKC, was not involved in the study design, subject consenting, data collection and analysis, decision to publish, or preparation of the manuscript. MKC was involved in the conceptualization of the study and review of the manuscript. TLB and KH are members of the Cooper University Hospital Institutional Review Board (CUH IRB) in the roles of unaffiliated scientist and affiliated biostatistician, respectively. Per the CUH IRB SOPs and HHS federal regulation 45 CFR 46.107(e), TLB and KH left the meeting before any motions were made on this study; were not present for any final discussions regarding the study; and did not participate on any votes regarding this study. This is reflected in the CUH IRB meeting minutes.
(© The Author(s) 2023.)