Clinical trials are the springboard for progress in modern healthcare, guiding the development and evaluation of new treatments and next-generation therapies for patients. Trials exist at the critical juncture where scientific innovation meets real-world patient care and offer the promise of improved health outcomes and an enhanced quality of life. Yet as innovative as clinical trials are, the industry itself is still ripe for innovation from within. The structure and setup of clinical trials, coupled with the technologies that facilitate them, play a pivotal role in shaping their success or failure.
The choices made in trial setup – from patient recruitment strategies to data collection methods – directly impact the success and cost of a trial. Efficiency is crucial at every point in the drug development process. The industry has moved from paper-based data collection methods to the use of electronic data capture (EDC) systems and healthcare providers have moved to electronic health records (EHRs). While these EHRs and EDC systems are digital, the connection between them mainly is not digital, but analog. This non-digital connection creates an opportunity for innovative approaches using technology to better streamline trial processes, enhancing data accuracy, reducing cost, and expediting the development of new therapies.
Data Transformation in Clinical Trials
The transformation from paper-based to electronic-based records has expanded exponentially. Clinical research has not been immune to this. More than 3.6 million data points were collected in a 2021 Phase III clinical trial, which is three times the amount collected in similar protocols ten years prior.1 As medical records transitioned to EHRs and clinical data moved from paper to electronic clinical forms in EDCs, electronic information has become more standard across the clinical research industry. If EDC is managed well, costs and errors should decrease. But this digital transformation has not been without hurdles, including adoption and technology.
In this white paper, we delve into the implications of EHR to EDC technology, dissecting its role in enhancing the efficiency, accuracy, and integrity of clinical trials, as well as the roadblocks keeping this technology from becoming standard at scale. We also share our perspectives on the future of EHR to EDC technology to innovate design and deliver better trials.
Undertaking EHR to EDC Integration
In July 2018 the U.S. Food and Drug Administration (FDA) published its guidance to “modernise and streamline clinical investigations through the use of EHR data”2 with motivation for clinical researchers to work toward “interoperable or fully integrated” EHR and EDC systems.3
Streamlining data collection, enhancing accuracy, enabling realtime monitoring, and facilitating seamless collaboration from patient data and sites to clinical trial teams for analysis and reporting through to regulators are compelling reasons for successfully integrating EHR to EDC. There are powerful benefits to EHR to EDC interoperability from site, clinical research organization (CRO), and sponsor perspectives, as well as some challenges as to why interoperability has yet to become universal at sites.