Why eSource Integration now
More data sources than ever before
With the massive increase in decentralized clinical trials and widespread use of wearables and other connected health devices, more data than ever before can be collected. The advantage is that now the data is captured electronically rather than manually, which increases efficiency and accuracy. eSource data in the context of a clinical trial also reduces the need for in-person monitoring. It also means that the study can capture more data points, or real-world data (RWD)—not just at the interval clinic visits, but ongoing data such as heart rate, blood pressure, movement, glucose levels and more from a wide range of devices.
COVID-19 changed views on processes and data
With Covid, the ability to support traditional clinical trials was heavily limited. No longer were staff able to travel around the world to monitor or perform monitoring or source data verification (SDV) tasks of trial data. That combined with the need to quickly analyze and validate treatments related to COVID, forced changes in how patient data was collected and analyzed. This also forced sponsors and CROs to build new processes and views on data capture, to work around the limitations that Covid created.
Realizing the potential of real-world evidence
Real-world evidence allows for broader views into and analysis of a bigger cross section of supporting data (not just clinical trial data), enabling more informed clinical decision-making. RWE can provide key information related to how treatments affect a greater population and how outside variables might play into the treatment or outcomes of the patient population. It can also be leveraged to secure reimbursement.
Steps for implementing an eSource strategy
First—review current processes to determine what aspects of your process would benefit from utilizing eSource.
Look at the EHR/EMR systems running at the sites to see what version they are running and what interoperability features are built in such as HL7 FHIR, OMOP, or HL7 CCD-A.
Determine which modules are installed in the electronic health record or electronic medical record and what types of data is being collected in named fields. It is more difficult to collect source data from note fields. So, try to review data elements to ensure the types of data collected can be exported via eSource. Even in a situation where only standard of care data, such as vitals, medical history, demographics, and con meds are available, there is still a great benefit to the site to be able to automatically collect and populate these elements.
We should work to develop additional standards to encourage interoperability between systems specifically for research. Allowing for efficient patient population identification and more decentralized clinical trial access will help to give a more diverse population the opportunity to participate in clinical trials.
Those that are looking to utilize eSource should look at studies where they can bring select sites online to assess how eSource changes their process. Understanding that to recognize the true benefits, their studies and workflow will need to change or be updated to better recognize the benefits of eSource.
Additional work should be done to leverage available data from devices such as wearables, mobile devices, and connected medical devices to allow more comprehensive and accurate real time/real world data collection not just from an EHR/EMR but also from patients at home or outside of clinical trial site visits.