The U.S. Food and Drug Administration encourages the use of new technologies, including electronic health records (EHR), for regulated clinical research. At a conference several years ago, one FDA representative spoke about the FDA guidance documents and initiatives related to this topic and asked, “What is it going to take?”
EHR data has been used to assess protocol feasibility, identify patients for research and seek safety signals for pharmacovigilance. EHRs have also directly auto-populated research forms in post-marketing studies and for safety reporting.
The ASTER (Adverse Drug Event Spontaneous Triggered Event Reporting) project, conducted by Pfizer with Harvard, demonstrated that drug-related adverse events could be reported in less than one minute, as compared to the typical ~35 minutes it took to complete a MedWatch form to fax to the FDA.
A recent study by Duke, using an EHR as an electronic source (eSource) to auto-populate electronic case report forms (eCRFs), resulted in time savings of 37 percent for data capture. Quality improved measurably, in terms of reducing transcription errors from 9 percent to 0.
Thus, the use of EHR for prospective clinical research and safety reporting has demonstrated time and cost savings; the ROI is apparent. The technical capabilities to conduct a clinical research study using EHRs have been available for years; the list of benefits is long, and they seem to outweigh risks. But, challenges obviously remain.
Current challenges to conducting studies using EHRs include concerns regarding:
- Lack of awareness and/or adoption of available technologies and standards
- Being ‘first’; fear of regulatory repercussions (e.g., FDA non-acceptance of data)
- Variations among EHR implementations/systems, health care data and standards
- Changing existing processes and roles
In addition, there are issues related to patient privacy, security and ethics, which in turn drive the generation of data use agreements and other legal documents that take time to develop and execute.
The challenges and how to overcome them will be discussed by a panel of experts at the Bridging Clinical Research & Clinical Health Care Collaborative on April 4–5. At this strategic forum, FDA representatives will present the latest on FDA guidance on the use of EHRs, mobile devices and real-world data in clinical research, as well as other innovative uses of technology and standards to streamline the way we conduct research today. Anyone interested in the potential benefits these opportunities will bring to patients and how to get involved should participate.