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 trustworthy platform 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.
Achievements & News
Registration is open for the annual conference of the European Institute for Innovation Through Health Data (i-HD) in Gothenburg, Sweden on 19-20 November. The theme this year is ‘Realising the value of health data, showcasing practical examples from research and healthcare’, and the conference will showcase how routinely collected health data (real world data - RWD) can be used to derive important knowledge insights###, possibly uniquely from large scale data, and how these insights can and should impact on decision making and healthcare strategy. There will be sessions on:
- pragmatic clinical trials - their role, methods and tools, results and impacts;
- international observational health data networks – communities and projects;
- learning health systems – the global landscape;
- hospital-led and patient-led initiatives to use health data to improve outcomes;
- a debate on the acceptability conditions for real world evidence - to inform regulatory decision making.
Any new treatment, diagnostic test or medical intervention must go through clinical trials to demonstrate that it is safe and effective. Large-scale trials require hundreds or even thousands of patients that meet specific criteria. They must have the particular condition that is under investigation – but there may be other restrictions such as age or previous treatments. Finding a group that fit all these criteria can be time-consuming and expensive. To solve this problem, IMI’s EHR4CR project set out to find a way to allow researchers running clinical trials to search medical records in hospitals across Europe to discover the number of potentially suitable patients per hospital. Through collaboration between pharmaceutical companies and 11 hospitals in five countries, EHR4CR developed a way of assessing the number of potential trial patients from the hospitals’ electronic records while maintaining the privacy of sensitive personal data. ### “We knew it was possible on a one-to-one basis to get data from a single hospital to find out if they have any suitable patients,” says project coordinator Mats Sundgren from pharmaceutical company AstraZeneca. “What we did was to research and develop a scalable solution for using electronic health records across many hospitals in Europe without jeopardising or violating data security.” Following the completion of EHR4CR, the platform has launched as a commercial service called InSite developed by specialist data company Custodix – one of the former project partners. This enables scientists to search electronic medical records for suitable patients within a growing network of European hospitals treating millions of people, without seeing any personal information about them. It is predicted that using the platform to speed up trial planning and recruitment could reduce the time taken to set up and run a clinical trial by three to six months.
The inaugural conference of the European Institute for Innovation through Health Data (i~HD) will be held in Paris, France on 10 March 2016. i~HD is a non-profit institute that was born out of the IMI electronic health records project EHR4CR and other related projects. Its mission is to guide and catalyse the quality, interoperability and trustworthy uses of health data, for optimising health and knowledge discovery.###
This inaugural conference will mark the launch of a novel European platform to support multi-centre clinical research. This operational platform, the result of EHR4CR, can connect securely to the data within multiple hospital electronic health record (HER) systems and clinical data warehouses across Europe, to enable a trial sponsor to predict the number of eligible patients for a candidate clinical trial protocol, to assess its feasibility and to locate the most relevant hospital sites. Also on the agenda is IMI’s EMIF, Europe’s largest ‘big data’ project in health. The conference will also spotlight the challenges and state-of-the-art approaches to improving the quality and interoperability of clinical data. i~HD will play an important future role in the development and quality labelling of interoperability standards, bringing together clinical and research domain experts, with patients, to help ensure that future standards support patient care, learning health systems and clinical research.
The event is invitation only; those who wish to attend should express their interest via this form.
IMI’s EHR4CR project has produced a new animated video detailing the project’s main goal: to significantly improve healthcare research by advancing the ability of industry and academia to securely analyse de-identifed electronic health records###, strictly complying with data privacy, ethical, regulatory and legal policies. The project will also enable hospitals to participate more efficiently in more clinical trial programmes and, ultimately, ensure faster access for patients to safe and effective medicines.
IMI’s EHR4CR project has produced a video explaining how the project works. The goal of EHR4CR is to build, validate and deploy a Europe-wide innovative technological platform to re-use data from electronic health records (EHRs) for clinical research ### purposes while ensuring compliance with all applicable legislative, regulatory, ethical and privacy protection requirements and policies. The video can be downloaded from the homepage of the EHR4CR website.
An overwhelming majority (95%) of stakeholders are in favour of using electronic health records (EHR) in clinical research, according to the results of a recent survey run by IMI project EHR4CR (‘Electronic health records for clinical research’).### The goal of the project is to come up with a platform and business model to enable the re-use of data from EHRs for clinical research in Europe. The EHR4CR team set up the survey to identify opportunities and challenges in this area. The survey gathered around 200 responses from researchers in academia, the pharmaceutical industry, EHR system providers, patients’ organisations and others. Most highlighted complying with legislative, regulatory, ethical and privacy requirements as a top priority for the successful use of EHR services for clinical research. ‘The results of this survey confirm a high interest in re-using EHR data for clinical research with the objective to optimise drug development efficiency and access to innovative medicines in Europe,’ the project team states. ‘This survey provides valuable information towards achieving the development and implementation of EHR4CR services and of a sustainable and scalable business model.’ The team’s findings will be published in a forthcoming issue of iHealth Connections.
ParticipantsShow participants on map
- Amgen, Brussels, Belgium
- Astrazeneca AB, Södertälje, Sweden
- Bayer Pharma AG, Berlin, Germany
- Eli Lilly And Company LTD, Basingstoke, United Kingdom
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
- Assistance Publique Hopitaux De Paris, Paris, France
- Cdisc Europe Foundation Fondation, Brussels, Belgium
- Ethniko Kai Kapodistriako Panepistimio Athinon, Athens, Greece
- European Institute For Health Records, Lille, France
- European Molecular Biology Laboratory, Heidelberg, Germany
- European Platform for Patients Oganisations, Science and Industry, Leuven, Belgium
- Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Erlangen, Germany
- Heinrich-Heine-Universitaet Duesseldorf, Düsseldorf, Germany
- Institut National De La Sante Et De La Recherche Medicale, Paris, France
- King'S College London, London, United Kingdom
- Les Hopitaux Universitaires De Geneve, Geneva, Switzerland
- Research In Advanced Medical Information And Telematics Vzw, Zwalm, Belgium
- The University Of Edinburgh, Edinburgh, United Kingdom
- The University Of Manchester, Manchester, United Kingdom
- Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev, Berlin, Germany
- Universitat Munster, Münster, Germany
- Universite De Rennes I, Rennes, France
- University College London, London, United Kingdom
- University Of Dundee, Dundee, United Kingdom
- University Of Glasgow, Glasgow, United Kingdom
- Warszawski Uniwersytet Medyczny, Warsaw, Poland
- eClinical Forum Association, Friesenheim, France
Small and medium-sized enterprises (SMEs)
- Custodix Nv, Sint-Martens-Latem, Belgium
- Xclinical GMBH, Munich, Germany
- Consept Consulting, Friesenheim, France
- Neptunus Data Aktiebolag, Saltsjöbaden, Sweden
|Name||EU funding in €|
|Assero Limited (representing CDISC) (left the project)||11 696|
|Assistance Publique Hopitaux De Paris||360 000|
|Cdisc Europe Foundation Fondation||168 304|
|Custodix Nv||549 750|
|Ethniko Kai Kapodistriako Panepistimio Athinon||71 280|
|European Institute For Health Records||558 734|
|European Molecular Biology Laboratory||20 000|
|European Platform for Patients Oganisations, Science and Industry||35 250|
|Friedrich-Alexander-Universitaet Erlangen-Nuernberg||339 750|
|Heinrich-Heine-Universitaet Duesseldorf||412 500|
|Institut National De La Sante Et De La Recherche Medicale||480 000|
|King'S College London||435 000|
|Les Hopitaux Universitaires De Geneve||339 750|
|Research In Advanced Medical Information And Telematics Vzw||345 951|
|The University Of Edinburgh||15 855|
|The University Of Manchester||330 000|
|Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev||266 250|
|Universitat Munster||553 500|
|Universite De Rennes I||339 750|
|University College London||660 810|
|University Of Dundee||330 000|
|University Of Glasgow||255 000|
|Warszawski Uniwersytet Medyczny||157 500|
|Xclinical GMBH||33 914|
|Name||Funding in €|
|Consept Consulting||92 900|
|Neptunus Data Aktiebolag||30 600|
|Total Cost||7 194 044|