(280) Remote Trial Elements Reported in Publicly Available Clinical Trial Protocols

Publication Number: 954

Background: Decentralized clinical trials which use decentralized or remote clinical trial elements – such as online participant recruitment, and data collection through wearables – are conducted away from investigative sites to make trials more participant-centered. The implementation of remote elements in clinical trials has several potential advantages, including collecting data closer to the real-world setting while still designing an interventional clinical trial. Insights into how remote elements are implemented in clinical trials can help identify areas of focus to drive the adoption of remote elements.

Objectives: To investigate the type and frequency of remote elements reported in publicly available clinical trial protocols from phases 2, 3 and 4 interventional clinical drug trials, in a cohort of clinical trials with a study start in 2019 and 2020.

Methods: Publicly available protocols from phase 2, 3, and 4 interventional clinical drug trials with a trial start date in 2019 and 2020 were downloaded from ClinicalTrials.gov. Two researchers manually extracted and peer-reviewed information on the reporting of predefined remote elements. These remote elements involved: participant outreach, screening, consenting, IMP supply, and data collection, which was further specified into (i) participant-reported outcomes (PROs), (ii) (wearable) devices or biomarker kits, (iii) home health visits, and (iv) telemedicine visits. Descriptive statistics were used to summarize the results.

Results: The study included 254 protocols, of which 46% was a phase 2 clinical trial protocol, 28% phase 3, and 26% phase 4. Of the 231 non-hospital-based protocols, the majority of the protocols (75%) reported on remote data collection. More specifically, 58% of all non-hospital-based protocols reported remote data collection through telemedicine visits, 45% reported remote data collection through participant-reported outcomes, 17% described the use of devices for remote data collection, and 9% described the use of home health visits. Remote data collection was most frequently seen in phase 3 (92%), when compared with phase 2 (77%) and phase 4 protocols (54%). Protocols from public sponsors reported more remote activities related to recruitment and enrolment compared to private sponsors – including remote outreach (30% vs 17% of the protocols, respectively), and remote consenting (13% vs 3%).

Conclusions: Remote data collection is commonly used in clinical trials, whereas other remote elements, such as remote participant outreach, were less frequently reported. Best practices for implementing remote elements should be identified and communicated to drive mutual learning between sponsors, and other clinical research stakeholders.