The European Medicines Agency (EMA) indicated that it supports the use of eSource direct data capture (DDC) in clinical trials. Its qualification opinion, released in September 2019, states that eSource DDC that is implemented correctly and compliant with Good Clinical Practice (GCP) can be used in support of regulatory filings. This has important ramifications for sponsors, CROs, and the industry as a whole.
The opinion is in response to a request by Novartis Europharm Limited for EMA feedback on the use of eSource in clinical trials. While the U.S. Food and Drug Administration (FDA) has largely been supportive of using eSource in clinical trials, the EMA had expressed concerns citing potential issues with GCP compliance and adherence to electronic signature and data custody legal requirements.
Having the EMA and FDA more closely aligned on eSource technology in clinical trials opens the doors for sponsors and CROs to deploy the technology across more studies.
The Metrics That Told the Story
Novartis included insight and data gleaned from several Phase I, II, and III studies using our eSource technology in its request. This provides real-world context for implementing and deploying eSource DDC in global studies. Regulators identified several critical differences in capturing source data electronically as opposed to simply implementing a traditional electronic data capture (EDC) system.
Although the EMA’s opinion doesn’t promote any eSource platform, it does include Novartis’ metrics comparing our eSource solution to traditional EDC systems:
- Time to data availability dropped six-fold.
- Number of data points that remained unchanged throughout the study increased 7%, indicating fewer changes because of data queries or monitoring.
- Time to resolve data queries dropped by more than half.
This and other evidence led the EMA to state in its opinion that, “eSource DDC has the potential to improve quality of data and lead to operational efficiencies.”
Clinical Ink — Pioneering eSource Technology
One important factor supporting the EMA’s opinion on the use of eSource platforms in clinical trials is that the clinical assessment and other source data is entered during the clinic visit. This ensures that the data is validated at the time of capture. The FDA’s 2013 industry guidance on eSource technology echoes this point. It states, “this guidance promotes capturing source data in electronic form” and “encourages entering source data during a subject visit” to have “real-time access for data review.”
Because we’re one of the earliest developers in clinical trial eSource technology, our comprehensive eSource technology is one of the only solutions available that meets the guidance from both regulatory organizations. Our eSource technology captures clinical source data and associated documents at the same time the information is recorded. Real-time data capture provides sponsors, investigators, and patients visibility and improves protocol adherence and execution. It also reduces trial risk and improves patient safety and engagement.
In the opinion request, Novartis reaffirms the point about patient safety by stating that it expects eSource DDC will enable better patient oversight and enhanced patient safety as all data, including adverse event data, is obtained from the eSource DDC tool.
Because our technology was built to capture clinical data at the point of care, investigator errors are minimized. Specifically, it reduces the amount of data that is inadvertently omitted or missing throughout the course of the trial. It can ensure that the data point is entered correctly and items of concern are flagged during data entry. The technology also optimizes sponsor monitoring and reduces the time to data lock.
Innovation Bringing Better Clinical Trials
The advantages of using eSource DDC in clinical trials over electronic transfer methods are clear — better operational efficiencies, convenient study data access, and improved data quality lead to well-informed decisions. But the biggest impact for sponsors and CROs is that the data can now be submitted to support a marketing authorization application (MMA) provided that it is otherwise GCP compliant.
Regulatory endorsements of eSource technology from organizations like the FDA and EMA make it easier for sponsors and CROs to implement the kind of innovative technology that is revolutionizing the way clinical trials are conducted. Despite growing evidence to support the use of eSource solutions for clinical trials, industry acceptance has been slow — mostly due to outdated process models. The EMA’s opinion should help to increase the adoption of these electronic data capture technologies industrywide. And, as an industry pioneer, Clinical Ink is lighting the way forward.