TBD: The Shifting Terrain - Trends in Use of Hybrid and Decentralized Trial Methods
Poster Presenter
Lisa Charlton
Senior Director, Product Development, eCO
Science 37 United States
Objectives
Summarize top-line findings from an expert survey on current and projected future use of hybrid and decentralized clinical trial methods
Method
Email outreach to Biopharmaceutical, CRO, and other individuals to complete a 5 minute, 16 question online survey in July 2022.
Results
155 individuals completed the survey: 54% from biopharma, 20% from CROs, and the remaining 26% from academic institutions, device/diagnostic companies, or government. 57% of respondents were based in North America and 71% worked for an organization with less than $1B in revenue. Half of respondents had conducted a hybrid/decentralized trial in the previous 12 months, and 69% planned to conduct one in the next year. Hybrid/decentralized adoption was similar for Phase II and Phase III studies with 54% and 52% reporting they had conducted a study in the past year, respectively. Planned use in the next 12 months was also similar with 63% and 69% planning a hybrid/decentralized study. As for use of specific decentralized components, respondents plan to increase use of all decentralized tools in the coming 12 months, with more than half reporting that they plan to use the following in the next year: ePRO/eCOA, Remote Patient Monitoring, Telemedicine and eConsent. Reduced Patient Burden was ranked the highest of the top three perceived benefits of adopting a DCT (63% ranked first, second or third). This was followed by Better Patient Experience (48% top 3) and Faster Patient Enrollment (44% top 3). Notably Greater Patient Diversity was rated in the Top 3 by only 26% of respondents. When asked about the top three challenges associated with incorporating a hybrid/decentralized approach into a clinical trial, Integrating Sites with DCT Elements and Regulatory Concerns had the greatest number of mentions in the top 3, 50% and 45% respectively. Data Privacy and Data Quality Concerns were only ranked in the top 3 by 28% and 26% of respondents, a marked decrease from last year’s survey.
Conclusion
The clinical trial industry will be increasing use of hybrid/decentralized trial methods over the next 12 months. To take advantage of the patient benefits, organizations will need to support change management for clinical trial sites.
