OSTP, ONC Seek Input on Optimizing Clinical Trial Electronic Data Capture

The White House Office of Science & Technology Policy (OSTP), in coordination with the National Security Council, issued a Request for Information (RFI) on October 26, seeking input on optimizing electronic data capture for clinical trials.

COVID-19 emphasized the need for a national clinical trials enterprise. In response, the Biden-Harris Administration released the National Biodefense Strategy, which calls for a clinical trial infrastructure “ready to administer candidate countermeasures to participants within 14 days after the identification of a viable countermeasure.”

“A key component in building US capacity for clinical research – both during a public health threat and at other times – is ensuring that trial data can be captured as a set of consistent data elements across separate trial sites under a coordinated clinical trial protocol,” OTSP and ONC officials wrote in a HealthITBuzz blog post.

“Currently, researchers must analyze different datasets, developed under different research protocols, stored in different formats, in data repositories that are often not accessible to all participants. This delays the development of evidence,” they added.

On October 28, OSTP issued a second RFI entitled “Data Collection for Emergency Clinical Trials and Interoperability Pilot” in partnership with ONC.

In this RFI, OSTP and ONC seek input on operationalizing clinical trial data capture and protocol distribution from a technical perspective.

“We want to know what opportunities technology can offer to create the data infrastructure needed to support a coordinated clinical research enterprise that can be activated when a health threat arises,” the blog authors noted.

Specifically, ONC and OTSP seek input on viable strategies to distribute clinical trial protocols and to capture clinical trial data using Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR)-based APIs.

Using common APIs to distribute protocol requirements and capture clinical trial data will allow healthcare organizations to communicate quickly and effectively.

“This will allow institutions to more rapidly understand a virus and to test new and repurposed vaccines and medicines, even when research is conducted across different kinds of healthcare and research settings with different electronic health record and research data systems,” the officials wrote.