One tool, many uses
By: Patrick Jordan, MBA, MA | March 02, 2016
How electronic health records can be used to generate evidence in support of both clinical care and clinical research.
In an era of skyrocketing healthcare costs, patients, providers, regulators and pharma are in desperate need of solutions that will help them rein in the cost of healthcare from drug development through to patient care. According to the Tufts Center for the Study of Drug Development, the cost of developing a new medicine doubled from 2005 to 2014—from $1.3 billion to $2.6 billion. During that same period, healthcare spending in the US increased from $2.0 trillion to $3.0 trillion, according to the Centers for Medicare and Medicaid Services.
Fortunately, the healthcare industry already has a tool in place that can shave costs and drive efficiencies for biopharma and healthcare providers alike — electronic health records (EHR). The EHR has been held out as a tool that makes healthcare delivery more efficient and ultimately less costly. A national survey of doctors who are ready for meaningful use — i.e., those using EHRs to improve health quality, engage patients, care coordination, and privacy — found most respondents saw benefits in care efficiency and cost savings.
A recent study published in the scientific journal “Contemporary Clinical Trials” shows biopharma companies can generate similar cost and time savings in their research. The findings of the European EHR4CR (Electronic Health Records for Clinical Research) 4-year project co-funded by the European Commission and by the European Federation of Pharmaceutical Industries and Association show that reusing EHR data for clinical research would improve clinical trial design and execution, and generate significant benefits. By connecting securely to the data within multiple hospital-based EHR systems and clinical data warehouses across Europe, the platform enables clinical trial sponsors to assess the feasibility of clinical trial protocols, identify eligible patients for recruitment, and ensure optimal data exchange during study execution, including for reporting serious adverse events. The platform is expected to increase the efficiency of existing clinical research processes, and speed up the development of new drugs.
What EHR can do for you
As the line blurs between clinical care and clinical research, where real-world data plays more centrally in drug development decisions, the EHR may bring the same positive influence to the drug development endeavor. EHRs have great potential to solve multiple challenges in both the clinical care and clinical research arenas:
Barriers to address
The fact that EHRs were designed primarily to handle billing, coding, and documentation means that they often need to be ‘retrofitted’ for use in clinical trials. IT departments are under pressure to get systems up and running as fast as possible, and ensuring that the health institution can treat patients is a top priority. Research sites are also cautious about what happens in the event of an FDA audit. Many have more experience and confidence with paper-based systems with physical signatures and anxiety about the potential for loss of data if electronic systems go down.
Lastly, the promise of the EHR depends on having good data within the EHR. The industry is making headway in this area but there are still enhancements needed in order for clinical data to be a natural byproduct of patient care such as improvements with interoperability, system flexibility, data standards and data governance. This requires expertise in EHR use, data and adoption, allowing the right data to be included in the EHR, incorporating this data in a way that promotes provider adoption, and then extracting the data to support new research and insights.