Article | November 14, 2023

Electronic Data Capture in Clinical Trials: What Needs to Improve?

Source: ISR Reports

By Jocelyn Reynolds

GettyImages- 1180547354 trial data

Electronic data capture technologies are constantly evolving to better serve the needs of complex clinical trials. Industry Standard Research (ISR) tracks this progress to provide greater understanding of the capabilities and service provider attributes users value, the technology’s positive and negative impacts, and how EDCs must grow to stay viable. 

When asked about their desired improvements to EDC systems, survey respondents from pharmaceutical sponsors and clinical research organizations (CROs) frequently selected improvements that align with findings on the top selection criteria for EDC system. “Improved integration with other eClinical technologies” regularly tops the list of desired improvements and important selection criteria for any eClinical technology, from EDC and electronic clinical outcome assessment (eCOA) systems to interactive response technology (IRT) and clinical trial management systems (CTMS). Ease of integration is also the EDC element respondents predict would have the greatest impact on clinical trial timelines.

Following improved integration on sponsor and CRO wish lists is enhanced user-friendliness for sites, lower cost, and faster build times. Notably, user-friendliness for sites ranks significantly higher than user-friendliness for sponsors and CROs, despite the latter two groups comprising the base of survey respondents. Sponsors and CROs may value the site experience more because they need site personnel to remain engaged in data collection activities.

Faster system setup/build times at the start of a trial (i.e., building the programming, testing data capture, ensuring the protocol and EDC system align and properly interact) are also a desired improvement. Similarly, sponsors and CROs indicated they value EDC system flexibility when build or programming changes become necessary mid-study.

From a market research perspective, it is difficult to say with surety what may be driving these trends. Cost and timelines come up in any discussion about desired improvements. Adoption often is slowed by difficulty in convincing senior management to switch technology systems because of concerns about cost or potential risk when partnering with an untested provider (i.e., they may not be sure how long the technology provider’s initial build will take, or how long it will take to implement mid-study design changes).

Still, it is clear that technology quality attributes — data quality, data reconciliation, integration across EDC and the various sources feeding into EDC — often win out over cost in terms of organizational priority. Large sponsors typically are willing to partner with a best-in-breed technology provider to avoid quality or performance issues.

More than half the time, respondents said they contracted through the CRO for access to an EDC system (whether that system was provided by a third party or managed by the CRO). Realistically, though, the EDC could be one of a number of items in a bundle of clinical trial costs within the CRO’s proposal. Similarly, the EDC system could be a line item in a larger bill of technology support when contracting a large, integrated technology provider.

Of course, EDC providers with whom ISR spoke had their own ideas of how their systems could be improved — or more efficiently utilized. In particular, they identified clinical trial operational efficiency as an area ripe for improvement (i.e., to optimize overall trial speed and/or cost). After all, technology cannot be expected to fix all timeline problems (e.g., slow patient recruitment or contract negotiations). 

Still, the more integrated technologies become, and the more they can seamlessly support different clinical trial elements, the more likely they are to promote faster time-to-market. The top area sponsors and CROs identified as likely to positively impact operational efficiency is best represented as “holistic study design” — specifically, integrating technologies (e.g., EDC, eCOA, and IRT) based on the protocol schedule of activities, rather than building the study in each tool separately.

The idea is to be proactive, rather than reactive, developing a protocol the technology can support, with specific systems in mind. That way, various clinical technologies can be easily integrated and the clinical operations team can understand the systems’ interactions with each other from the start.

CRO and sponsor respondents also stated operational efficiency would benefit from improved real-time aggregation and standardization of data, plus on-demand analysis. In short, sponsors want data in real time but are several steps removed from the investigational site and want to avoid lag while data are being entered and reconciled. That way, the data are fed to various analysis and reporting tools in real time.

Furthermore, respondents expect EDC systems to continue improving on data review and query generation, using AI to help the project team recognize data issues and push out automated queries to sites to reconcile those issues.

To learn more, access ISR’s EDC Benchmarking and Market Dynamics (5th Ed.) here.