FDA to Test Ability to Capture Electronic Data in Clinical Trials

Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process.

The 2013 final guidance, Electronic Source Data in Clinical Investigations, was meant to encourage the use of electronic source data in INDs and NDAs. However, since that time there have been few Phase 3 trials using electronic data capture, CDER spokesman Stephen King says.

The projects the FDA wants to support should assess and report on the value and challenges of an electronic health record-to-electronic data capture single-point capture of source approach in a clinical trial. King says the FDA will determine the number of demonstrations after reviewing responses following the close of the comment period.

Stakeholders — industry, EHR and EDC vendors and academic medical centers — interested in participating in the demonstration projects should respond to www.regulations.gov by Aug. 10.

View last week’s Federal Register notice at www.fdanews.com/06-26-15-EHR.pdf. — Kellen Owings