How eSource Ensures Data Integrity in Clinical Trials
In the evolving landscape of clinical trials, electronic source (eSource) data capture is revolutionizing how clinical research teams ensure data integrity. Traditional paper-based processes for capturing source data can be time-consuming, costly, and error-prone.?
In this article, we explore the:
The Shift from Paper-Based Source Data to eSource
In the past, clinical trials heavily relied on paper documents for source data capture, including:
These paper-based documents were routinely distributed, completed, reviewed, monitored, and filed as the primary form of source data.
Today, eSource data capture tools like eConsent, electronic case report forms (eCRFs), and electronic patient-reported outcomes (ePRO) are becoming increasingly mainstream. This shift from paper to electronic source data presents novel ways to approach data verification.
Challenges with Traditional Source Data Verification (SDV) and Risk-Based Monitoring (RBM)
Traditional source data verification methods have significant drawbacks. For instance, TransCelerate BioPharma reported that only 2.4% of data corrections result from SDV, yet another evaluation showed it consumes up to 40% of a trial's budget. Amid rising drug development costs, this is an unrealistic expense for many companies.
Regulators have also encouraged a transition from traditional on-site monitoring in favor of developing strategic monitoring processes. As far back as 2013, the FDA released guidance for risk-based monitoring (RBM), replacing its original guidelines that required 100% SDV for clinical trials.?
Many newly developed methods for RBM utilize technology to:
To allocate resources more efficiently, RBM strategies include centralized, remote, and reduced monitoring. Despite these advancements, SDV remains a prominent activity during on-site monitoring visits, posing financial challenges for clinical research teams with limited budgets.
Leveraging eSource for Clinical Trials
As clinical trials become more decentralized, eSource offers an attractive alternative to RBM for alleviating the burden of SDV. Researchers can electronically capture and sync data directly to their clinical data management system from various sources, including:
The Vision of Fully Electronic Source Data
A 2020 article in the Therapeutic Innovation & Regulatory Science journal envisions a future where all source data is completely electronic and fully accepted by regulators worldwide, emphasizing the importance of eSource implementation.
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Implementing eSource solutions may help:
Implementing eSource technologies like direct data capture (DDC), electronic clinical outcome assessment (eCOA), ePRO, and eConsent into a site's workflow can improve data integrity by reducing human intervention.
In addition to improving data integrity, eSource is more cost effective compared to traditional SDV methods by eliminating costly, time-consuming data transcription. By eliminating paperwork and data transcription from paper to electronic systems, eSource streamlines the data capture process.
Implementing eSource in Clinical Trials
While eSource offers numerous advantages, implementing it in clinical trials presents challenges. A shift in mindset is required to consider only electronic data as source data, transitioning away from mixed paper-electronic models.
According to the 2020 article mentioned above, fully embracing eSource “will require a change in mindset from what is currently considered ‘source data’ (i.e., a mixed model of paper and electronic source data recorded at the point of generation) to a future state that considers only electronic data as source data, when data are initially recorded in electronic form.”?
Addressing Interoperability Challenges
Interoperability constraints can hinder the seamless integration of eSource technology with existing systems. Data standardization, such as CDISC and HL7 FHIR, may alleviate these challenges, but it necessitates collaboration among various stakeholders, including participants, sponsors, technology vendors, standards organizations, and regulators.
Regulatory Guidance on eSource
Regulatory bodies have expressed interest and provided guidance on clinical source data in eSource, like the:
However, further alignment on eSource guidance is essential to promote data integrity, privacy, security, and interoperability.
The Promise of eSource Technology
Despite the associated challenges, the benefits of eSource technology are substantial. eSource holds the promise of reducing the exorbitant costs associated with traditional SDV methods while simultaneously enhancing data integrity. As eClinical innovation advances, clinical trial teams should consider implementing eSource to expedite timelines and reduce costs.
eSource data capture is a transformative solution that ensures data integrity, cost-effectiveness, and regulatory compliance in clinical trials, making it a vital tool for the future of clinical research.
To learn more about how eSource is shaping the future of clinical research, watch our latest webinar featuring leaders from across the industry.
Contributing Experts: Rod McGlashing, Subject Matter Expert of Data Science at Medrio;? Tina Caruana, Subject Matter Expert of eClinical Solutions at Medrio