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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:

  • Unlock insights from patient data. Last year Johns Hopkins University announced that its researchers used EHR data to develop a model of 27 variables that correctly predicts septic shock in 85% of cases. With sepsis, where hours matter, identifying which patients need intervention has a tremendous impact on clinical outcome. These analytics help caregivers uncover hints in a patient’s chart—hints that otherwise may be overlooked or identified too late—that a problem is developing. In the same way EHR algorithms can trigger customized treatment plans, they can also be used to identify patients that might be eligible for clinical research opportunities. Researchers at Cincinnati Children’s Hospital Medical Center published results last year to illustrate the efficiency of using EHR data to identify potential trial participants. The team collected eligibility criteria on oncology studies that took place at their institution and developed an algorithm to extract EHR data from oncology patients admitted for care over the same period. By comparing actual recruitment performance on a reference set of historical trial participants to an automated screening of EHR data, the researchers found they could achieve an 85% reduction in the workload to match patients to research studies. This efficiency gain can translate to faster care decisions and more research options for patients.
  • Reduce unnecessary tests and procedures. Duplicate medical testing is a significant contributor to laboratory and imaging utilization, which translates to increased costs. One assessment showed that using EHRs to gauge lab test frequency reduced high-cost assessments by 23%. Relevant EHR data might also be leveraged to reduce unnecessary or duplicate procedures and tests in clinical research.  The Tufts Center for the Study of Drug Development estimated that 20% of procedures conducted in later stage clinical trials collects extraneous data,which amounts to $4-6 billion in avoidable biopharma spending. While these additional procedures are often used in pursuit of exploratory endpoints in studies, mining EHR data could achieve similar objectives at less cost. 
  • Streamline data collection. One of the primary reasons EHRs were created was to ease the administrative burden of capturing patient information on paper and establish a central repository for all of a patient’s healthcare experiences. Mount Sinai Medical Center reported that EHRs reduced transcription costs by $5.6 million. The clinical research arena has pursued similar gains in converting paper-based data instruments to electronic data capture (EDC) formats. The next step is connecting these data streams. In mid-2015, the FDA requested proposals to test demonstration projects to test an end-to-end EHR to EDC single-point data capture.  Such an effort puts interoperability — often just associated with getting different EHR systems to relate to each other — to more demanding requirements as EDCs enter the picture. But the benefits can be significant, with higher quality data, reduced costs of data collection, and the possibility of more widespread participation in research among physicians limited by the “logistical complexity” of conducting trials, as ACRO put it
  • Generate evidence. As EHRs replace paper, an enormous opportunity opens to analyze care patterns and research possibilities. In clinical care settings, a Chief Quality Officer of a large hospital system can assess, for example, the variation among network hospitals in using evidence-based order sets to treat patients and the impact on outcomes. In clinical research, where new therapeutics are investigated over the relatively short period of a drug study, assessments of the safety and efficacy of marketed products can follow a much longer arc of data in the EHR. Janet Woodcock estimated that arc to represent 350 million person years as she described Mini-Sentinel, a pilot project sponsored by the FDA to monitor the safety of regulated medical products.

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.