A key component in building U.S. 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. 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. When time is of the essence, dataset incompatibility can become an unacceptable obstacle, inconsistent with our goal of rapid pandemic preparedness and biodefense.
On October 28, OSTP issued a second RFI related to the innovative clinical trials goal of the National Biodefense Strategy. This RFI was prepared in partnership with the Office of the National Coordinator for Health Information Technology (ONC) and is entitled “Data Collection for Emergency Clinical Trials and Interoperability Pilot.” …
We know that innovators have begun to develop technical strategies to improve data capture in clinical trials. One driver of this innovation has been ONC’s work to establish a regulatory and governance foundation for the interoperability of electronic health records (EHRs). Among other initiatives, ONC is currently supporting the development of the United States Core Data for Interoperability (USCDI) standard; FHIR APIs; and Substitutable Medical Applications and Reusable Technologies (SMART) platforms that are compatible with FHIR interfaces, giving rise to “SMART on FHIR” APIs.
The challenge now is to develop strategies for electronic capture of clinical trial data that can be used by unrelated institutions and study sites that participate in the same clinical trial. These strategies must be deployed in both the emergent and non-emergent settings… Read the full article here.
