Accurate, effective data is vital to the success of any clinical trial, but collecting this data is challenging. Typically, during a clinical trial, a patient goes to a site for their visit and their information is entered in the Electronic Health Records (EHR) system. When this information is needed as part of an Electronic Data Capture (EDC), someone needs to go into their EHR, pulls up the data and manually enters it into a database.
This is just the initial process for transferring data from EHRs to EDCs - when data needs to be corrected, it adds up to three or four iterations of work before the problem is resolved. "The existing process is manual and labor intensive, time-sensitive and error-prone," says Gene Vinson, Executive Director of Clinical Vendor Management and Global Procurement at Syneos Health®. And these delays can significantly impact clinical trials, according to Vinson and his team.
“Every time you touch a data point, you're adding cost,” explains Vinson. “And if you reduce the number of times you touch something, then you've decreased the overall cost of production.”
The costs associated with manual entry of data from clinical trials have led many throughout the industry to look for greater accuracy and efficiency in data capture: By automating data transfer from EHRs to EDCs, developers have been able to eliminate transcription errors while simultaneously reducing the time it takes to complete this process.
In addition, if the EDC can be proven to reliably reflect the EHRs when using direct data transfer systems, site managers could potentially reduce or even eliminate onsite source data verification (SDV), which is one of the largest source of cost in a clinical trial. It will allow for resources to be focused on risk based monitoring which drives better data review and decision making.
In a recently conducted proof of concept exercise using proXimity, when data was transferred directly from the EHR to a EDC database, the data transfer was five times faster than manual entry and the data was transferred with 0% data entry errors, compared to a 3.5% error rate for manual data entry.
“This kind of direct data transfer answers many of the problems that site coordinators have been trying to solve for years,” says Vinson. “It reduces the amount of work involved for sites from data entry to queries by significantly reducing transcription errors, allowing site monitors to use their time on site more effectively. This system allows site coordinators to quickly send data to EDC as soon as it is entered into EHR, dramatically reducing time to data entry. This technology has the potential to transform how clinical trials are run.”
Syneos Health has over nine years of experience with EHR integration solutions and we believe this data transfer system could also prove invaluable for Real World Late Phase and Decentralized Clinical Trials (DCT) as well, given the growth of DCTs as a result of the COVID-19 pandemic. “Making data collection instantaneous from a variety of remote sites, instead of requiring someone to collect data or needing patients to hand deliver that data, could not only save time and energy, but also greatly reduce the possibility of collection errors,” notes Gene Vinson.
Clinical trials face a wide array of challenges at every level of the process, and as the COVID-19 pandemic showed, new challenges will continue to emerge. Direct data transfer from EHRs to EDCs has the potential to streamline one of the most important, difficult and time-consuming parts of the clinical trial process. This technology can make a real difference in clinical trials, allowing decisions on safety and efficacy of investigational medicinal products to be more reliable and delivering those treatments to market with greater speed and quality, thereby making a real difference in patients' lives.
If your team is looking to better understand or manage the data from your clinical trial, contact the Syneos Health Clinical Data Management team today.
Exec Director, Clinical Vendor Management, Global Procurement