Without a doubt, I wholeheartedly believe EHR-to-EDC integration is the future of clinical trials.
There are at least 10 reasons why clinical trials need to prioritize EDC eSource, including:
- EDC eSource eliminates manual re-entry of EHR data.
- EHR to EDC adoption is now 98 percent.
- The 21st Century Cures Act requires an API based on the FHIR standards.
That said, not everyone is quite as bullish as I am about eSource.
For the SCDM Annual Conference, I chaired a session by the same name as the title of this blog, EHR-to-EDC: The Way of The Future Or a Pipe Dream?
I was joined by:
- Anosheh Afghahi, MD, Medical Director, Flatiron Health
- Rajesh Modi, Business Capability Lead, Merck
- Manny Vazquez, Director, Vault CDMS Strategy, Veeva and
- Andrew Wyman, Product Owner, OpenClinica
The benefits of EHR-to-EDC integration
I kicked off our session with some introductory remarks. I highlighted the benefits of EHR-to-EDC integration, including:
- Reduces data entry, queries and SDV,
- Lowers burden for sites, and
- Gets higher-fidelity data for faster decisions
I also raised some important questions, such as:
- Which studies and settings are best? I believe best practices need to be more widely disseminated to scale.
- How do we accelerate implementation timelines?
- What data is accessible and how do we assess quality and completeness?
80% of oncology data is available in the EHR and eligible for EHR-to-EDC transfer.
Dr. Afghahi was our first speaker. She discussed a study conducted at Flatiron Health that used five oncology studies across phase 1 to 3 trials with different tumor types, solid and hematologic malignancies, and assessed the data element volume for the patient who was on the study for the longest duration. The study determined that ‘about 80 percent of structured and unstructured oncology trial data is available in the EHR for study purposes and eligible for EHR-to-EDC transfer.’
She cautioned that
we need to focus on the site and increase the voice of the site for us to understand how to best deliver this technology,” and stressed, “eSource will need to have the ability to transfer all types of data variables, structured and unstructured, in order for [eSource] to be worthwhile for the sites.”
Our next speaker was Veeva’s Manny Vazquez. He is more reticent about the future of EDC eSource. He focused on a number of promising use cases for eSource, including oncology, rare diseases and early phase investigator-initiated studies. Vazquez stated:
In oncology, they generally have EMRs (EHRs) into which they capture all their data. In rare diseases however, there may only be 6 or 7 institutions in the entire country that are researching the indication that you’re working on…and they could probably get on board because scale has always been the problem.”
Andrew Wyman of OpenClinica detailed six important considerations for successful integrations:
- Security reviews
- Legal/Contracts
- Hospital IT team assembly
- Resource dedication
- Defining precise data elements for the trial
- Getting the stamp of approval from hospital stakeholders
EHR-to-EDC best practices
Our concluding speaker was Rajesh Modi of Merck. He discussed his organization’s best practices and framework.
One: Accept the data structure as is – Keep it simple for sites
- Robust and validated ETL (extract transform load)
- Focus on structured data
- Be flexible – incremental vs. cumulative file transfer
- Hybrid process – transfer data available in the EHR and augment the rest via data entry on case report forms (CRF)
Two: Due diligence
- Site qualifications and business assessment is required to confirm ‘fit for purpose’
- Technical and operational feasibility analysis
- Assess the impact on the processes
Three: Equipment
- Set-up and test the data flow using a locked study
Four: Pilot
- Use non-pivot/non-registration study
- Conduct SDV as to the current process and then transition to risk-based SDV
Five: Scaling
- Gather feedback from internal and external stakeholders, ensuring readiness
- Invest in change management and training both internally and externally
Six: Business Continuity Plan (BCP)
- Enable data entry in CRF for unforeseen circumstances
If you’re ready to select an eSource tool, I urge you to read my recent blog, Choosing the Right EHR-to-EDC Solution for Clinical Trials. In the blog, I detail nine essential questions, including:
- How will data be structured and filtered for the sponsor or CRO?
- What results have been achieved with other clinical trial clients?
- How does the solution integrate with existing user workflows?