Source data is the initial data recording, and eSource is any source data that is recorded electronically with the goal of producing the highest quality data—faster. eSource methodologies and collection methods include Direct Data Capture (DDC), electronic outcomes assessments (ePRO/eCOA), and electronic health or medical record (EHR/EMR). eSource simplifies the data collection process by digitizing source data from the start and eliminating the need for transcription and the risk of transcription errors thereby producing cleaner, more reliable data.
With the immense growth in the expense and complexity of clinical research over the past decade, outsourcing overseas has become an attractive option to streamline costs, timelines, and patient recruitment. Regulatory harmonization initiatives have helped facilitate multi-regional clinical trials, and many countries now provide incentives to make them more enticing research destinations. Take a look at this:
Since the primary reason for outsourcing overseas is to develop life-saving treatments more effectively, it’s vital that new logistical challenges don’t get in the way of that goal. Therefore, as research sites, sponsors, and participants are spread farther across time zones and hemispheres, it’s more important than ever to leverage solutions that facilitate communication, data sharing, and smooth workflows.
While solutions to new research challenges brought on by globalization aren’t always simple, eSource goes a long way. For us at Medrio, this means Direct Data Capture (DDC), eConsent, and ePRO; however, this technology takes many shapes, including wearables, electronic health records (EHRs), and other formats. With strong support from regulators, these tools are highly valuable for global clinical trials thanks to their ability to capture high-quality, easily traceable data that can be shared worldwide in real-time.
With outsourcing overseas showing no signs of slowing down and many industry leaders signaling that eSource will soon become the primary mode of data collection, investing in this technology is a central way that researchers can protect cost and timeline gains while bringing life-saving treatments to market faster. Here are 3 reasons why eSource in global trials is a must:
The demands for higher data quality and the growth of clinical trials in regions with limited infrastructure underscore eSource’s value. Not only does this technology facilitate data capture and real-time sharing, but also it ensures the quality and traceability of that data. For example, Direct Data Capture (DDC) that syncs directly to EDC can reduce transcription errors by 90%, and real-time edit checks help verify that all input is accurate and compliant.
Global researchers can see the impact of eSource. We’re excited about the international collaboration with one of our US-based clients working with sites in Yemen to develop a cholera vaccine. Leveraging direct data capture, site staff quickly gather data offline when Internet connectivity is limited and sync it automatically to EDC when a connection is reestablished. US staff can then instantly view and assess that information, allowing teams to work together from opposite sides of the globe more effectively.
Managing paper-based trials presents challenges, even without great distances. A recent study showed that printing costs alone for a trial of 500 participants could run up to $50,000. Add the time, expense, and complexity of paper-based monitoring in global clinical trials – shipping paper overseas, flying monitors across oceans for site visits – and the cost and time commitment can grow exponentially.
eSource has the potential to improve efficiency in this area vastly. A customer of ours, Australia-based Linear Clinical Research, conducts global trials for sponsors and CROs in China and other countries. While Initially using paper, they were able to significantly enhance site operations with the help of direct data capture. They reduced paper usage by 95%, monitoring visits by 50%, and gained near-real-time visibility into data for faster decisions. As a result, they were able to scale up the number of studies they conducted.
Patient recruitment is widely known as one of the top challenges that clinical researchers face – a key driver of outsourcing overseas is to speed up the recruitment process. It’s also well known that better patient engagement means a more efficient research process.
Even if a region has a vast potential patient pool and a cultural openness to trial participation, ensuring participant comprehension and reducing burden are two ways to keep patients enrolled and engaged. Wearables, Electronic Patient-Reported Outcomes (ePRO), and eConsent give patients the flexibility to provide valuable research data with fewer site visits and ensure that they fully understand what a trial entails. This, in turn, gives researchers a leg up and promotes a faster route to regulatory approval.
Even as we grow further apart geographically, technology can bring us closer to breakthroughs than ever before. eSource and its many forms mean that data can be shared faster, allowing researchers exciting new opportunities that weren’t possible even a few years ago. Embracing eSource is now a crucial step that organizations must take to make leaps in productivity and quicken the tempo of developing life-saving treatments – and those who act the fastest position themselves for the most significant impact.