By Jocelyn Reynolds
Per the FDA, decentralized clinical trials (DCTs) include any trial in which one or more components are separate from the investigators’ location. While nearly half of respondents to Industry Standard Research (ISR) surveys on the topic indicated they are mostly satisfied with electronic data capture (EDC) technology performance in DCTs, almost none said they were completely satisfied. In short, EDCs are not completely missing the mark in DCT applications, but they have a lot of room for improvement.
Mirroring our discussion about general EDC improvements desired by pharmaceutical sponsors and clinical research organizations (CROs), improved integration topped the list of respondents’ stated desires regarding unmet needs related to EDC usage in DCTs. Most often, respondents wrote in data integration — between EDC and electronic clinical outcome assessment (eCOA) systems, electronic patient-reported outcome (ePRO) systems, interactive response technology (IRT), and eConsent systems.
Direct data capture (i.e., remotely, via devices) for patients is equally prioritized as an area for improvement, based on write-in responses. The root cause for many of these responses is a desire to reduce or eliminate duplication of effort.
Additionally, sponsors and CROs reported frustration with the lag that commonly occurs in data reconciliation — caused by having to download data from various electronic sources, then enter that data into the EDC system as a central data repository. As more clinical trial activities occur off-site, more data can go missing. With fewer face-to-face patient visits with investigators and fewer monitors traveling to sites to perform in-person source document review, sponsors and CROs are anxious to ensure their data is being accurately captured in the EDC.
Some respondents wrote in variations of “improve remote monitoring capabilities.” Essentially, sponsors and CROs want to see more capabilities related to remote source data review and verification in EDC systems. Other respondents stated they constantly encounter data quality issues, requiring them to query sites to reconcile those issues. Excessive site burden during DCTs also was a common refrain among respondents, particularly the expectation that sites make sure all patient data is being captured by these systems (e.g., potentially forcing the site to enter data multiple times across several systems).
Even beyond our questions covering EDC performance in decentralized trials, the desire to minimize patient burden and improve patient experience is near universal among respondents. While EDC is not considered a patient-facing technology, it is a means for sites to capture data and for sponsors/CROs to ingest that data more conveniently through direct data capture elements.
This likely is part of the reason electronic patient-reported outcome (ePRO) systems are only used in a portion of trials that leverage EDC. While decentralized trials present some improvements for patients, the protocol may require the EDC to plug into more systems, and may be more burdensome to patients (e.g., if the protocol requires them to fill out questionnaires, or use multiple different electronic devices or paper, etc.). Thus, while EDC system improvements might not seem to have a direct relationship with patients, better integration between EDC and other data sources reduces friction for sponsors, sites, and patients alike.
For better or worse, sponsor and CRO predictions relevant to usage/adoption of a given technology, or improvements in various areas of clinical development, tend to be overly optimistic. For example, we regularly ask their predictions for such improvements over the next several years. However, after that time has passed, usage or improvements rarely reach the levels respondents predicted.
Still, sponsor and CRO respondents stated that, on average, nearly one-fifth of their trials have collected patient data transmitted from sensors and/or wearables (e.g., glucose meters, spirometers, and/or activity meters) directly into an EDC system. They also predicted that roughly one-third of trials will use direct data capture over the next two years.
That said, the DCT space (and clinical trial space, as a whole) currently is dominated by a limited number of EDC systems, since sites simply are most familiar with those vendors and products, and sponsors are most comfortable with them. While alternatives have emerged, promising to cut down on build timelines and the bulky nature of these legacy systems, the inherent risk of change stymies that progress.
Accordingly, newer, nimbler providers face a steep climb if they want to convince sponsors to sunset traditional EDC in favor of direct data capture only, or a unified decentralized trial platform that everything plugs into. So, the question remains, will EDC evolve to fix its existing problems, or will a different type of decentralized trial platform (or single platform model) replace pick-and-pull, add-and-subtract modules of clinical trial technology? Ultimately, given their market dominance, legacy EDC providers are likely to decide the answer.
To learn more, access ISR’s EDC Benchmarking and Market Dynamics (5th Ed.) here.