A special guest blog post by Jennifer Price, Senior Director of Clinical Data Management, Paidion Research
The many steps, as well as associated labor and time, of manually recording and transcribing clinical trial data into a database are significantly reduced with electronic source data (eSource). Implementing eSource is a single initiative that saves time and money, provides higher quality data, and streamlines your clinical research. Yet, I still often hear from clients that they are reluctant to start capturing source data in electronic form. In this eSource blog series, I’ll discuss eSource implementation – benefits, challenges, guidelines, getting started, and best practices – beginning with the benefits here.
Advantages for Patients.
For patients, eSource eases time commitments and overall burden, by allowing them to remotely submit data as well as potentially decreasing in-person clinic visits. Mobile health (mHealth) technologies are also gaining popularity, with increased smart phone use and a growing interest in health and fitness. This means that clinical trials can leverage these devices to remotely collect data, ranging from simple survey-based information to biological, behavioral, and environmental information. With more control over when and where their data are collected, patients reportedly feel more empowered and engaged, and compliance is often better. Broader patient representation can result from the inclusion of patients who might not otherwise participate (e.g., incapacitated, remote/rural residence) or who are reluctant to provide sensitive information to the clinician in person.
Improved Data Quality.
Eliminating the error-prone task of having a human transcribe information provides higher quality data by improving accuracy (7% versus 1% erroneous data). Also, data checks during data collection mean that fewer questions are missed, providing a more complete data set for every patient. More uniform patient data collection helps ensure the quality, integrity, and reliability of the source data.
Monitoring, Traceability, and Transparency.
Once the data is centrally available (often in near real-time), monitoring can kick in – remote, risk-based monitoring. Data monitors can view data trends in the central database and identify sites that might need additional training or oversight, focusing their effort where it’s needed most. Full audit trials of any changes are typically available, and all changes are made in the original source, improving traceability. For these reasons, regulatory agencies are encouraging the use of eSource.
Challenge Leads to Rewards.
In light of these clear benefits, why hasn't the industry seen a wider adoption of eSource? In short, change is hard, and there is a steep learning curve. The advantages of eSource, including saved money and time, reduced errors, and faster data access, are worth the investment.