The U.S. Food and Drug Administration (FDA) has shed further light on why it wants electronic health records to be part of drug trials, acknowledging that it may spur the use of electronic source data and speed up the drug approval process.
In a webinar held July 7, Ron Fitzmartin, senior advisor of the Data Standard Program with the FDA's Center for Drug Evaluation and Research's (CDER) Office of Strategic Programs, noted that electronic data capture was slow to catch on by industry, but is now "ubiquitous." However, very little is being done with trials using eSource technology, despite the fact that the FDA had issued guidance on the topic almost two years ago and guidance on standardized study data, which will be required in the next few years, was issued in December 2014. The FDA wants see the direct use of EHRs for clinical research in regulatory submissions and wants to partner with companies to conduct demonstration projects. This is the reason why the FDA released its notice June 26 expressing an interest in the concept.
"We're very eager to see paper going away," Fitzmartin said.
The benefits of using eSource technologies for clinical trials include the reduction of transcription errors, elimination of duplicative data, facilitation of remote data monitoring, more accurate and complete data, a traceable end-to-end data flow and more timely collection of the data.
Fitzmartin added that the technologies can have a "transformational change" and that the FDA wants to encourage and be a part of that.
The FDA's interest in EHRs is not surprising. Research has shown that EHRs can both simplify and improve clinical trials.
The agency envisions that the EHR would serve as the source of electronic data for the clinical trial, which would be stored in the trial sponsor's clinical trial management system; the FDA then would review the data, said Mitra Rocca, senior medical informatician with CDER's Office of Translational Services, also speaking on the webinar. It is the FDA's plan to be able to streamline clinical research and "get medicines to market faster," she said.
The demonstration projects the FDA is interested in supporting would test the capability and evaluate the performance of using a single point, end-to-end EHR-to-Electronic Data Capture (EDC) approach, using standardized study data. The FDA has no particular demonstration projects planned and is looking for companies and others to propose them. Proposals can be made via the FDA's "broad agency announcement" on fedbizops.gov, Fitzmartin said. Comments and requests to participate are due Aug. 10.