Authors:
Rod McGlashing, Subject Matter Expert, Data Science at Medrio
Tina Caruana, Subject Matter Expert, eClinical Solutions at Medrio
In the past, paper-based source data was the raw material that made up clinical trials but this is changing as eSource data capture becomes more mainstream.
Previously, paper documents like consent forms, case report forms (3-part NCR), site worksheets, lab reports, and participant documents like questionnaires and diaries were routinely distributed, completed, reviewed, monitored, and filed. But now, source data has expanded to the electronic realm.
Electronic source (eSource) data capture using tools such as eConsent, eCRFs, and ePRO is becoming increasingly mainstream. This expansion presents unique ways of thinking about data verification.
All medical device trials require comprehensive data verification for the sake of safety, integrity, and regulatory compliance. For years, manual source data verification (SDV) has been used to ensure data quality and trial integrity. Researchers aimed to identify potential errors by laboriously comparing data entered into an electronic data capture (EDC) system to its primary paper source.
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As trials have become ever more complex, eSource data capture offers a more efficient and cost-effective way to achieve data integrity. Here’s why.
Challenges with SDV and Risk-based Monitoring in Medical Device Clinical Trials
There are significant challenges associated with traditional source data verification methods. For example, in a 2013 position paper, TransCelerate BioPharma (a non-profit organization with a mission to collaborate across global biopharmaceutical research and development) reported that only 2.4% of data corrections are a result of SDV—while another evaluation showed SDV can eat up a whopping 40% of a trial’s budget. Amid rising drug development costs, this is an unrealistic expense for many companies.
Meanwhile, regulators are encouraging a pivot away from traditional on-site monitoring towards the development of strategic monitoring processes. In 2013, the FDA released guidance for risk-based monitoring (RBM), thus replacing its original guidelines which required 100% SDV for clinical trials.
Many newly developed methods for RBM use technology and software to monitor data collection while flagging potential high-risk areas that merit closer scrutiny. To more efficiently allocate resources, RBM includes strategies such as centralized, remote, and reduced monitoring.
Despite all of this, source data verification remains ingrained in the clinical trial industry as the main activity during on-site monitoring visits. With many medical device developers trying to innovate on limited budgets, they cannot afford the exorbitant costs of a process that the right tools can essentially eliminate.
eSource for Medical Device Clinical Trials
As clinical trials become more decentralized, researchers need a way to capture, see, and manage data across devices, sensors, wearables, telemedicine, and digital health technologies.
Among its many other uses, eSource offers an alternative to risk-based monitoring (RBM) for alleviating the burden of SDV. It allows researchers to capture data electronically, right at the source, and sync it directly to their clinical data management system.
A 2020 article in the Therapeutic Innovation & Regulatory Science journal reported that the desired future state of clinical research is “one in which all source data, acquired through any context (e.g., healthcare delivery, chronic disease management) and actor (e.g., healthcare professional, patient, caregiver), are completely electronic, adequate in quality, and fully acceptable in clinical trial submissions by regulators worldwide.”
How can this be accomplished? Leverage eSource to integrate direct data capture (DDC), electronic clinical outcome assessment (eCOA), ePRO, and eConsent into a site’s workflow.
The same authors noted that adopting eSource will “improve data integrity by allowing direct data flow from the source to the sponsor’s system, with minimal or no human intervention.”
Importantly, eSource is much more cost effective than traditional SDV methods. By eliminating paperwork, it also eliminates the time-consuming (and therefore costly) need to transcribe data from paper to EDC—the very process that makes SDV necessary in the first place.
Implementing eSource in Medical Device Trials
While eSource is an excellent alternative to SDV, some challenges are associated with implementing it in a medical device trial.
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.”
Besides a shift in thinking, there are challenges tied to integrating eSource technology with existing systems due to current interoperability constraints. These challenges may be overcome, in part, through data standardization (e.g., CDISC and HL7 FHIR). But doing so requires collaboration between multiple stakeholders, including participants, sponsors, technology vendors, standards organizations, and regulators.
Many regulatory bodies have expressed interest and/or provided written guidance on their expectations regarding clinical source data in eSource, including the:
- United States (US) Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
This is a good start—but further alignment on eSource guidance will help to better promote data integrity, privacy, security, and interoperability. According to the 2020 journal article above, doing so “requires transformative change management to foster adoption and minimize the burden of implementing eSource.”
Despite associated challenges, the benefits of using eSource technology are significant.
eSource holds the promise of reducing the huge costs in clinical trials typically associated with SDV while improving data integrity. As eClinical innovation advances, medical device clinical trials are wise to consider the implementation of eSource to reduce timelines and cut costs.
If you are interested in learning more about how ePRO affects medical device clinical trials, explore our white paper that’s filled with data-backed insights.
