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, and, in some cases, may mean that a trial cannot take place at all. As a result, patients miss out on potentially beneficial new therapies.
To solve this problem, the EU and industry-funded 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. Europe has the strictest data protection laws in the world, so if we could solve this problem here then we could solve it for anywhere.”
We are the champions
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.
Not only does the technology help researchers work out whether a proposed trial is feasible or not, it also reassures patients that their data remains secure. 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.
Building on the collaborations established during EHR4CR, a group of pharmaceutical companies is now acting as ‘Champions’, sponsoring and encouraging hospitals across Europe to engage in the initiative. Another important outcome from the project is a non-profit collaborative organisation, the European Institute for Innovation through Health Data (i~HD). It brings research groups, hospitals and companies together to find the best, most efficient and trustworthy ways to use and share patient data to improve health.
Collaboration is key
For Sundgren, the biggest challenge has been convincing so many stakeholders to work together – especially large pharmaceutical companies that are more used to being competitors than collaborators. However, the strong working relationships that have emerged are an essential part of the success of the project.
“We worked together for so many years, sharing the same vision,” Sundgren says. “It’s not just about the technology – it’s about the relationships and the interactions between people and organisations that lie at the heart of it.”
He is enthusiastic about the potential for InSite, i~HD and the Champions programme to make a real difference in the future.
“It’s really new, but it will have a big impact,” he says. “The scope, the challenge and the opportunities are very rewarding – we can influence not only the agenda for the pharmaceutical industry but for the research community and the whole of society to use electronic health data to bring better treatment for patients. It’s been a long journey but we have changed things, and that’s very rewarding.”
The project was funded by the Innovative Medicines Initiative, a public-private partnership between the EU and the European pharmaceutical industry.
- Project acronym: EHR4CR
- Participants: Sweden (Coordinator) France, UK, Germany, Greece, Belgium, Switzerland, Poland
- Project N°: 115189
- Total costs: € 16 643 429
- EU contribution: € 7 194 044
- Duration: March 2011 to February 2016
Source: European Commission, Research and Innovation Information Centre