There’s a single word that captures the spirit of business since the start of the pandemic: “direct.” Brands are adopting direct-to-consumer models wherever possible to trim time and costs from the distribution chain. And it’s not that different in the data world. “Direct” is the catchword of the day.
Most clinical trial data can now be collected directly and automatically — at the moment of inception — without the need to transcribe and verify source records or integrate software. This direct-to-database model is far simpler, faster, cleaner, and compliant than paper-based methods. And, with the right eSource platform, trial data can be aggregated, integrated, and classified to accelerate data analysis for insight-based decisions in real time.
Direct Data Capture: What’s Not to Like?
Direct Data Capture (DDC) technology ingests trial and patient source data captured directly at the source. The speed and directness of eSource data offers a number of advantages to Sponsors over traditional paper-based methods of recording trial data and even over limited-use electronic data capture (EDC) systems. Foremost among these are:
- Improved study oversight. With role-based visibility to data in real time, study teams can intervene as needed to reduce risks and monitor patient progress in a timely fashion.
- Greater control over protocol execution. eSource technology provides automatic calculations and includes instructions to reduce errors. Guided information entry protects against protocol deviations, ultimately reducing the number of data queries.
- Accelerated decision making. There is no lag time since eSource data doesn’t need to be transcribed, loaded, verified, and integrated.
- Higher quality data. With Direct Data Capture technology, there’s less room for human error. There is no transcription. No patient diaries hurriedly completed in the clinic parking lot. No errors or omissions in visit records. The technology flags missing, erroneous, or inconsistent data based on pre-determined logic.
- Use of digital biomarkers. With advances in wearable and sensor technologies, state-of-the art instruments specific to a therapeutic area can be developed to complement existing assessments and augment traditional clinical trial data. Our work to date has demonstrated that mobile devices can be easy for patients to use, secure, and valuable in detecting disease and tracking patients’ ongoing status. In time, we believe that they will be used in conjunction with other scales to determine an individual’s disease probability, severity, and risk for progression, with applications in clinical trials as well as medical practice.
- Time and cost savings. When data are captured electronically from the source, there is no need for it to be transcribed into a software program nor is there any need for Source Data Verification (SDV). Plus, the process generates fewer data queries and streamlines the query management process.
Naturally, clinical development, operations, and IT leaders seek to rationalize and optimize the mix of technology available to support their trials. Given the digitization of trial data, the ideal solution supports real-time data collection into a single eSource ecosystem that is scalable, sustainable, and customizable.