In the last few months, at IDC Health Insights, we had some very interesting conversations about the innovation potential the new generation of integrated patient records can bring to clinical research and in the acceleration of the "bench-to-bed" value chain, for the European healthcare sector. While the healthcare sector is, very slowly, but surely advancing in the integration of information for care delivery, when it comes to research, and in particular to clinical trials, we are at the beginning of a new but quite fascinating path.
At IDC Health Insights in the past two years, we analysed in depth the evolution of EHR systems in Europe , describing how they need to meet the more flexible, agile, and usable demands of the new integrated care ecosystem. When investing in EHR, healthcare providers are trying to move toward more nimble environments that leverage application-independent data repositories. The aim is to make EHR a new platform for collaboration across the health value chain, something that generally is beyond the scope of the original investment. Healthcare providers are starting to integrate of EHR with other different sources of patient information ( from medical images, videos, o patient generated data, to devices etc.), trying to achieve a 360-degree patient view that yield great potential not only from a more personalized and integrated care perspective, but from a clinical research one as well.
Nevertheless, university hospitals and medical research centres are struggling with how to re-use EHR patient data to automate key clinical trials processes such as, for example, patients' selection, cohort segmentation, protocol validation, reporting etc. These processes are currently handled through paper-intensive processes and custom solutions to collect, clean and report data to research sponsors, which makes the whole process very paper-intensive and not scalable.
As already described in our IDC Health Insights FutureScape 2015, the opportunities coming from a re-use of EHR, and other clinical care data, are paradigm changing, and a common approach to data management and use will allow European countries to be at the forefront, providing a safer and more dynamic environment for research. An ecosystem able to provide the infrastructures and the knowledge for example for advanced phases of clinical trials as phases 3 or 4, when researchers need to gather information from larger and diverse groups of people, and deliver more in depth analysis on the drug's or the treatment's effect in the short and in the long term-use ( e.g. pharmacovigilance).
The key issues that healthcare providers are encountering in using EHR data for clinical research emerging first initiatives are fivefold:
- Trust and Change management: clinicians that work as staff scientists often do not trust the quality of data collected in EHR, because they believe doctors and nurses in the ward do not pay enough attention to the details they need, or not with enough consistency to support clinical research; so they prefer to rely on dedicated data managers that collect and manage the data specifically for research purposes
- Data architecture: the key data concepts (entity and attributes) of EHR are engineered to document the single episode, or at best the individual patient, rather than longitudinal records about a number of patients undergoing a clinical trial; so staff scientists find it easier to rely on custom solutions used only for clinical trials, rather than extract data from EHR and then have to clean, combine, enhance them
- Compliance: secondary use of data is not allowed under all European data protection laws and even though the level of sophistication and trust of anonymization tools is, in some cases, still immature
- Interoperability: working with multiple pharma companies, each of them with their reporting templates is a problem that makes very hard to scale the number of clinical trials that an individual hospital can deal with
- Study approach: with personalization of care, in particular, with the additional omics data, the methodologies used to validate the effectiveness and safety of a treatment will increasingly deviate from the traditional clinical trial approach.
Healthcare providers are looking for some guidelines and common approach and In Europe there are a number of initiatives aimed at creating a guideline framework for integrating EHRs and clinical research information systems, as for instance:
- IMI (Innovative Medicines Initiative) is developing the EHR4CR, an open IT platform that unlocks the information stored in EHRs for improving clinical research, while ensuring patient privacy and ensuring a high level of security.
- The EU funded INTEGRATE project which aims to develop innovative infrastructures and tools to bring together heterogeneous multi-scale biomedical data for breast cancer research, including clinical trials management systems, eCRFs ( electronic case report form) , and hospital EHRs.
The journey is really at the beginning, but initial experiences are showing that among the key success factors for this kind of initiatives we find the ability of healthcare providers to:
- standardize and implement comprehensive, but flexible, information governance systems, securely handling patient data;
- exploit the integration of 3rd Platform technologies to enable better consolidation and more automated extracts from patient data (ideally at or near the point of data generation).
The integration of clinical care information in the value chain of clinical research is one the key themes of the third IDC Pan European Healthcare Executives Summit "Removing friction, harnessing the convergence, making integrated care work", which will be held in Dublin on September 22nd and 23rd 2015. If you're interested in sharing your organization experience in this fascinating topic, please have a look at the event website and get in contact with us. See you in Dublin