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. 2023 Oct 6;7(1):e232. doi: 10.1017/cts.2023.643

Table 2.

Description of decentralized methods used and study outcomes

Study Decentralized method Intervention and comparator Primary outcome Secondary outcome
Adams et al., 2022 [17] Health applications, at-home drug administration, wearable biomarkers, eConsent, and smartphone application Use of decentralized tools to reduce travel and time for clinical trial participation Patient likelihood to enroll in cancer trials
Ali et al., 2020 [18] Siteless, online recruitment, ePRO via smartphone application, and eConsent Use of patient-centric, siteless, reward-based, and remote trial of patients with atopic dermatitis Success with nationwide recruitment, identifying patients with variable disease severity, adherence, and dropout
Ali et al., 2021 [19] Online recruitment, eConsent, online video calls, ePRO via smartphone application, and wearable biomarkers Use of DCT design elements Ability to recruit, enroll, and engage patients
Josan et al., 2021 [20] Online recruitment, eConsent, ePRO via smartphone application, online visits, and study-supplied BP cuff and EKG sensors Integration of decentralized technologies into a virtual trial experience for patients Ability of a large phase 3 cardiovascular DCT to achieve quality results and withstand health crises
Magnani et al., 2021 [21] Smartphone application, telephone-based consent, ePRO, mail-based delivery of assessments, and virtual recruitment Telephone-based orientation and verbal consent obtainment. Patients were randomized to either receive a smartphone with intervention or control group applications. Study assessments were sent by mail with telephone-based administration and contact for trial duration. Successful adaptation to virtual engagement and recruitment
Myers et al., 2022 [22] Online recruitment, digital biomarkers, virtual visits, and ePRO via smartphone application Remote decentralized observational Parkinson's Disease (PD) studies with video visits Recruitment processes and outcomes
Ng et al., 2021 [23] Virtual recruitment and remote virtual trial Double-blind, placebo-controlled, multicenter study was conducted using both a virtual site and a traditional site Recruitment efficacy and dropout
Sarraju et al., 2022 [24] Online recruitment, eConsent, ePRO via smartphone application, online visits, and study-supplied BP cuff and EKG sensors Integrating digital health technologies into a decentralized clinical trial Feasibility and success with recruitment, protocol adherence, and engagement
Sedhai et al., 2022 [25] Telemedicine, remote monitoring, and virtual recruitment Use of telemedicine, remote monitoring, and institutional oversight to conduct initial steps involved in a clinical trial at a rural satellite hospital Success with screening, consenting, and enrolling subjects
Sedhai et al., 2021 [26] Remote monitoring and virtual recruitment Activating through remote monitoring a multicenter clinical trial at a rural satellite hospital
Slomovitz et al., 2021 [27] Virtual visits, ePRO, and shipping of drug to patients Incorporating FDA, CDC, and NIH guidelines, implementing remote monitoring and other remote activities, enhancing enrollment opportunities, and increased frequency of meetings with industry Describe how the pandemic affected accrual to GOG Partners’ trials
Sommer et al., 2018 [28] Direct data capture, eConsent, ePRO, wearable biomarkers, virtual visits, and virtual recruitment Conducting trial with decentralized, conventional, and mixed model clinical trial settings Comparing decentralized, conventional, and mixed models for conducting a clinical trial Comparing operational and recruitment methodology of the models, assessing participant satisfaction, physical activity, and body posture, and evaluating patient compliance with reporting via eDiary
Yiannakou et al., 2022 [29] Virtual visits, ePRO, eConsent, and virtual recruitment Enterosgel for the treatment of IBS-D with diarrhea compared with placebo Percentage of responders in the treatment group compared to placebo group