How To Overcome Operational Challenges with DCT Implementation
One of the challenges some sponsors face in designing decentralized clinical trials (DCTs) is getting the data to flow through the trial efficiently from multiple sources. How do you get data passed smoothly from digital recruitment to eConsent to enrollment? What happens when you need data from both EDC and DCT platforms to synchronize for a specific participant? Start adding Home Health solutions and study sites in multiple regions, and the story can be even more nuanced. This can leave some teams frustrated working between multiple providers with unique requirements attempting to avoid delaying study startup and first patient in (FPI). However, there are ways to improve the flow of data through the trial design process, automated data flow, and platform provider.
Solution #1: Include DCT Design Thinking Early in the Process
As soon as a protocol synopsis is planned, DCT design thinking should be included in the process. Early design with decentralization in mind can help avoid the trap of building a traditional trial and then trying to add DCT elements on top at the end. Decentralized and hybrid protocols should be tailored to the specific needs of the study phase and indication to maximize the effectiveness of tech enablement. While the core requirements for clinical trial designs have not changed with decentralization, there are critical shifts in when, where, and how data is collected. If your team is new to decentralized trials, it can be a good idea to add Design Consulting from a reliable DCT provider. They can help you map your data flows with decentralization in mind.
Solution #2: Integrate Clinical Trial Automation Early
Automation is a critical element for effective decentralized trial execution. Setting up automated processes within a platform and across technology solutions can significantly decrease waste throughout study execution. Processes that once required manual entry or cross-checking may be set up automatically to capture data more efficiently and decrease human error. If a sponsor is using multiple decentralized solutions, for example a digital recruitment company, a home health provider, and a DCT platform, it is helpful if conversations between these parties are conducted early to allow adequate time for required automations to be built.
Solution #3: Deploy an Integrated Platform
The most valuable analytics driven insights come when more data flows through a single dashboard, including eConsent, ePRO, Survey, EDC, and telehealth visit status. Many solutions provide some eCOA or eConsent, but if you just pick and choose from multiple vendors, you may end up with a data flow nightmare. Small niche providers may create additional complications, costs, and delays for integration. Consider running your study through a centralized platform with smooth integrations that make the overall data flow smoother for participants, sites, CROs, and the sponsor. An added value of integrated platforms is an analytics dashboard with automated information on trial performance. Data analytics dashboards help study teams who need a way to track compliance within studies in as close to real-time as possible. One use case for compliance data is if a participant is close to missing a data collection window, a site could be notified and reach out to the participant to encourage them to remain compliant. These insights allow study leaders to anticipate potential issues and intervene before they become real problems. That’s the power of automation.
Getting data to work smoothly in decentralized trials isn’t just about getting a slick-looking app with API integration. You need to think about DCT during the design phase, get the right automations built between providers, and use an integrated platform that generates automated real-time analytics. For more info, contact threadresearch.com.
Noah Goodson, Ph.D.
Associate Director, Consulting, THREAD
Noah is well versed in the complex needs of these organizations and has spent significant time in guiding business development and scientific communication strategies with investors. As part of THREAD Consulting, Noah applies practical experience in running trials with a decentralized approach to build more efficient and inclusive studies.