Clinical trials, a necessary step in any new drug development, are expensive and complex. They are governed by strict regulations, and recruiting and retaining the right patients can be difficult. The rapid development of targeted therapies and personalised medicines is increasing the demand for efficient, patient-oriented trials with easier access to patient data.
The project Electronic Health Records for Clinical Research (EHR4CR) aimed to improve the design of patient-centric trials by developing a trustworthyplatform that provides access to existing patient electronic health records (EHRs). The objective of the platform is to help figure out if a trial is feasible; make patient recruitment easier; automate the preloading of a patient’s EHRs into a trial data collection form; and use EHR information in the reporting of serious adverse events during a trial.
A search platform to find the right patients
The main outcome of the project is the commercial platform InSite. Launched in 2016 following the completion of the project, it was developed by project partner, Custodix. It enables scientists to find suitable candidates for trials by searching millions of EHRs stored in hospitals and clinical data warehouses throughout Europe while maintaining patient privacy. Routinely used for feasibility assessment, the platform allows a clinical trial sponsor (e.g. the pharmaceutical industry), to predict the number of eligible patients for a clinical trial, and to locate the most relevant hospital sites.
This helps overcome one of the biggest bottlenecks in current clinical trials: slow and costly patient recruitment. The time dedicated to patient recruitment represents about 30 % of the total length of clinical trials, more than any other clinical trial activity, and almost half of all trial delays are caused by recruitment problems.
The InSite platform enables hospitals to efficiently identify and contact the patients who may be eligible for particular trials, saving time and money. In April 2019, the global health research network TriNetX acquired Custodix and the InSite network, making it the world’s largest platform for clinical research. The platform has increased speed, reduced cost, and improved accuracy in clinical trial design, helping the public, academia and industry in their goal to improve healthcare.
An independent oversight body
The neutral, non-profit European Institute for Innovation through Health Data (i~HD) was established in 2015 and arose in part from the EHR4CR project. It brings together research groups, hospitals and pharma companies whose mission is to find the most efficient and trustworthy ways to use and share patient data. The i~HD, which governs the InSite platform, provides independent oversight of clinical research platforms and their expanding networks of hospitals. It also tackles the challenge of scaling up innovations that rely on high-quality and interoperable health data.
The i~HD developed two services: DQS4H (Data Quality Service for Hospitals) assesses and improves the quality of EHR data for hospitals by measuring and improving health outcomes, thus attracting more clinical trials and conducting more research; and the QS4RP (Quality Seal for Research Platforms) is a process for the independent assessment and verification of how clinical research platforms and services handle data in accordance with information governance, security requirements and public and professional expectations.
Targeting the global clinical trial market, projected to be worth EUR 61.2 billion by 2026, the i~HD is also taking part in two projects: EHR2EDC (From Electronic Health Records to Electronic Data Capture systems), to improve and commercialise InSite; and Trillium-II (EU/US Cooperation for Global Interoperability in Digital Health), to coordinate efforts towards an interoperable, international patient summary.
The Champions programme
In 2015, before the development of InSite, EHR4CR consortium industry partners the i~HD and Custodix developed the Champions programme, which connects 11 European hospitals. By sharing their EHR data, the hospitals were able to participate in more clinical trials which allowed them to potentially increase their research income. For their part, the industry partners gained early access to InSite, which allowed them to optimise clinical protocols through direct responses from updated hospital EHR data for ongoing trials.
Based on the results of the EHR4CR project, the Champions programme provided the value of real-world data for clinical research and the InSite technology on a large scale. Completed in 2017, the Champions programme resulted in a European network of more than 50 hospitals, as well with the EFPIA Champion partners’ continuing collaboration.
The results of EHR4CR paved the way for another IMI project called EHDEN. Building on the output of EHR4CR, as well as IMI projects EMIF and HARMONY, EHDEN aims to harmonise clinical data and develop a 21st-century ecosystem for real world health research by building a federated network of data of 100 million EU citizens standardised to a common data model.
EHR4CR proved that the reuse of EHRs offers an opportunity for the advancement of medical research. It provides the academic community with tools and services to better plan and conduct academic trials, and facilitates comparative effectiveness research.
Through the programme, the pharma industry was able to improve the speed and quality of the patient recruitment process and study design by getting a better understanding of real patient populations. It also helped them conduct observational and outcomes research studies in real-world settings. The reuse of EHR data allows more efficient management of public health issues, resulting in the improvement of healthcare, the enhancement of patient safety and more evidence-based diagnosis and treatment.