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eSource for Clinical Trials: Exploring Challenges & Opportunities

eSource — the electronic capture of clinical trial source data — first gained traction in the late 2000s as technologies like electronic health records (EHRs) and electronic patient diaries became more prevalent. Designed to replace the manual collection and entry of data, the goal of eSource has been to make capturing clinical data more efficient, accurate and less costly to oversee.

The most prevalent eSource consists of commercially available systems that mimic paper source. The data collected by study coordinators and investigators is entered directly into an electronic database, which is then used to complete the case report form (CRF). The day will come when the systems talk to each other and remove this manual data transcription step.

The first such process is already happening for electronic devices that capture patient data directly. Some examples are e-diaries, ECG machines, blood glucose sensors and electronic blood pressure cuffs. These collection devices dump electronic data directly into the CRF with no need for transcribing. Unfortunately, efficiency gains from removing human intervention are often offset by technological failures.

The use of technology in research is moving toward systems that communicate and create efficiencies in research data transfer to the CRF. Dr. Elena Christofides, a Remington-Davis physician that specializes in endocrinology and metabolism, has used eSource since its very start. Since then, she has experienced firsthand the challenges of working with different eSource systems for clinical trials and their impact on research.  Her experience highlights a need for better integration between systems before eSource data can be directly transferred to the CRF.

Dr. Christofides spoke about these eSource hurdles — as well as opportunities — in an episode of the Society for Clinical Data Management (SCDM) Podcast. Here are some of the key takeaways from that conversation.

It's Hard Getting Clear, Clean Data Into eSources

In theory, digitizing initial data collection from the patient interaction into eSource results in a cleaner database with fewer pieces of discrepant data and fewer transcription errors. In practice, the process of using eSource creates an additional set of problems largely related to implementation and interface shortcomings. Implementation requires technical build and end-user education. Using multiple platforms controlled by a host of vendors leads to interface issues that can result in data loss due to the incompatibility of systems.

Digital Tools in a Clinical Trial Can Further Complicate Things

A clinical trial can rely on a number of digital tools from different vendors and platforms. When a sponsor or CRO wants all the information from an approved device (such as e-diaries) to integrate with a third-party vendor system, complications can arise.

Instead of working with device manufacturers and using their software and data, some sponsors and CROs opt to work with a third-party company for data collection and data integration. Yet, these technology companies don’t have in-depth knowledge of how these various systems work. At the same time, if a product isn’t consumer approved, it hasn’t gone through the proper user interface testing and the data collected may not be reproducible or valid.

This dynamic can create frustrations for clinical trial participants, study site staff and sponsors. Patients can find themselves making extra visits to the study site to try to get their study provided data collection devices to work and effectively communicate with the data capture systems. Missing time from work and other obligations can ultimately lead patients to drop out of trials.

There's a Need to Connect With Device Manufacturers

Device manufacturers have already invented the wheel when it comes to data collection and integration. Trying to circumvent this to support this “purity of data” concept only takes more time and cost. Instead of adding more middleman vendors to clinical trials, the goal should be to involve Original Equipment Manufacturers (OEMs) who already know their device.

With true data integration, clinical researchers can protect the integrity of trial data in an efficient and cost-effective way. By integrating proven systems and using them as intended or by engaging with the manufacturer for research-related functions, the data will be cleaner and the process will be more friendly for all constituents. 

To hear more from Dr. Christofides on the topic of eSource in clinical trials, stream the full SCDM Podcast episode: