Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection

The FDA’s real-time clinical trials (RTCT) initiative aims to improve clinical trial execution time and reduce subsequent delays in regulatory decisions. The effort to accelerate product development by the FDA is no surprise, as clinical trials for new medicines generally take 10 to 12 years from discovery to regulatory approval.

Yet, making progress toward real-time studies won’t be about reducing the time it takes to get a trial past its scientific limits. The impact will be felt when the industry can cut the non-value tasks that research sites and clinical teams work through every day. This includes stakeholders manually interpreting, cleaning, and moving data between systems and the extra steps it takes to submit it for review.

A connection between the sponsor’s electronic data capture (EDC) system and a hospital’s electronic health record (EHR) through a solution like electronic source (eSource) provides the key infrastructure necessary to streamline unnecessary added processes and enable RTCT. The technology to do this exists today but it has not been effectively deployed beyond a handful of studies or one-off system-to-system integrations.

The FDA’s real-time vision is dependent on building a distinct, native digital bridge between healthcare delivery and clinical research. With a scalable eSource, the industry can eliminate paper and manual data transcription in trials for more efficient and effective research.

Eliminating paper workflows for speed

The discreet digitization of data is critical to making RTCT a reality. While efforts are underway by many organizations, 67% of patient consents are still completed using paper. Source data captured on paper ends up manually scanned by sites into clinical systems. To more quickly filter through documents, companies often use optical character recognition (OCR) or AI on top of scanned paper.

Adding tools on top of scanned documents can automate transcription and aggregation but it doesn’t address the underlying process, like AI reading different handwriting and the significant time and effort it takes for sites to reconcile it. The approach only creates a faster workaround and remains an expensive tokenization issue for the industry and a transcription exercise with risk of human error.

To truly eliminate paper from clinical trials, industry stakeholders must first agree on standard digital data definitions before any trial activities are executed. The alignment sets the foundation to use AI for faster analysis, instead of feeding unformatted documents into an inefficient workflow.

Enabling industrywide standards for better collaboration

Regulatory agencies can be influential in aligning the industry, providing guidelines and standards that detail acceptable ways to capture or submit data. While competing data standards exist, including CDASH, CDISC, and NCQA, the industry faces a problem of excess.

Competing standards aren’t helpful until regulatory agencies get behind them and enforce them. Adopting an industry standard without regulatory enforcement is like changing the color signaling a stop on a traffic light from red to blue. This creates an adoption issue for the driver and a need to invest in new traffic lights.

USCDI in healthcare provides a blueprint for successfully implementing an industrywide standard. Once enforced, USCDI drove industry alignment by mandating Fast Healthcare Interoperability Resources (FHIR) for connections to other health systems. For the FDA and EMA, establishing a broadly accepted standard is a foundational piece to making RTCT a reality.

Deploying an operational bridge for data sharing

eSource captures discrete, standardized data at the point of care. Yet, why hasn’t eSource addressed the challenge of paper in clinical trials? Because life sciences companies haven’t been able to successfully scale eSource implementations beyond a single study or technology system integration.

A solution designed to meet the specific needs of clinical research sites and integrated with sponsor EDC and hospital EHR systems offers a new approach to source data capture. A site-centric eSource that leverages FHIR supports sharing patient-level health data in a standardized, secure, and compliant way.

The holistic approach enables repeatability for sites as a standard practice versus custom integrations for every study. Scaling eSource beyond a single trial allows sponsors to leverage a wealth of longitudinal patient data already captured in EHRs, and sites to eliminate the use of paper and scanning during execution.

An EHR-to-EDC connection that shares data in a standardized and compliant way across studies is mission-critical for RTCT. The approach of bolting on multiple applications to mirror eSource simply digitizes existing waste and isn’t a sustainable long-term strategy.

Progressing toward real-time clinical trials

Meaningful advancement toward RTCT requires digital data, standards, close industry collaboration, and new ways of working that prioritize high-value activities. Shifting from traditional approaches towards end-to-end data flow across hospital, site, and sponsor will take effort from all parties involved.

Key for sites is preparation for adopting and managing modern technology. Sites can expect to see an increase in IT costs and significant change management to upskill staff. The evolution will be similar to the historic shift of hospitals adopting EHR systems, where 80% of all hospitals in the U.S. and Canada use one today. A renewed focus to training site staff on new processes, with clear plans that enable adoption are needed to ensure the successful deployment of tools like eSource.

For sponsors and contract research organizations (CROs), reevaluating clinical trial strategies will be important. If every sponsor and CRO is investing resources into solving data sharing and interoperability in trials, it is likely they are working alone on a solution. Industry alignment on standards to work better together, consistent funding for sites, and a deeper focus on change management are initial steps to advance trials forward.

With this foundation in place, sponsors can then deploy agentic AI to streamline execution through digital labor. For example, implementing agentic AI with a risk-based quality management (RBQM) strategy enables the AI to do most of the data reviews for the human, flagging only the most important data for checking. This removes hours of traditional work for staff, time that can be better spent helping patients. The broader industry advancement in agentic AI opens the door for critical trial processes, like statistical review and data aggregation, to be handled by agents in a compliant and sustainable way.

Considering the impact of privacy regulations and AI

Looking ahead at the outlook for RTCT, hurdles remain because of patient privacy regulations. Passed decades prior, HIPAA didn’t account for the level of data sharing required by a RTCT. A site is legally allowed to transmit data directly to a regulator outside of HIPAA, but the guidelines around a sponsor holding and interacting with the data are conflicted.

Current legal frameworks don’t provide clarity around who owns the de-anonymized data. Is it the patient, the health system, the sponsor, or the technology vendor? As the FDA and its partners continue a path to execute RTCT, updated regulatory guidance is needed to prevent future setbacks.

Making a real-time, agentic clinical trial possible

Once an EHR-to-EDC highway is established, it will provide a foundation for smart AI. AI models will be safely implemented to deploy digital labor that automates manual processes and gives back valuable time to investigators.

Clean upstream data will allow these AI models to efficiently handle data aggregation, table joining, and RBQM. The advancements will be significant for accelerating clinical trials and moving toward the real-time execution the FDA is striving for. If done at scale across studies and sponsors, sites gain efficiency and speed, and sponsors get real-time, accurate, trusted study data.

Nick Frenzer, general manager, Veeva site solutions