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 |