The U.S. Food and Drug Administration (FDA) has announced its interest in considering the use of electronic health records with electronic data capture (EDC) in order to improve clinical trials for new and investigational drugs.
In an notice published in the Federal Register last Friday, the FDA's Center for Drug Evaluation and Research stated that it was interested in supporting demonstration projects to test the capability of and evaluate performance of using an end-to-end EHR-to-EDC single-point data capture approach, using established data and implementation standards in a regulated clinical research environment.
The project would "ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow," according to the notice. Stakeholders could include EHR and EDC vendors, academic medical centers and others.
EHRs continue to demonstrate their value in research projects, making it easier to identify and recruit patients for clinical trials as well as using EHR data to conduct research itself.
"The electronic capture of data from EHRs and healthcare devices, such as electrocardiogram management systems, digital imaging and mobile health devices, as well as electronic Patient Reported Outcomes Instruments, has the potential to improve the reliability, quality, traceability, provenance and integrity of data from electronic source to regulatory submission," the notice says.
For instance, such a process has the potential, among others things, to eliminate duplication of data, improve its quality, make research easier and facilitate the FDA's inspection of it.
"Streamlining clinical research at the source may open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research and get medicines to market faster," the notice says.
The notice also poses questions, such as whether there are any perceived regulatory obstacles to the use of EHRs with EDC to conduct clinical trials.
Requests to participate are due by Aug. 10.
To learn more:
- read the notice