Key Takeaways
- In response to the COVID-19 pandemic, the White House Office of Science & Technology Policy and the Office of the National Coordinator for Health Information Technology take a major step towards testing interoperability capabilities in clinical trials.
- The regulatory and technological framework for the interoperability of Electronic Health Records platforms could be applied to the clinical trials context.
- Shift towards the use of interoperable technologies could improve the collection and exchange of clinical trials data between institutions in emergent and non-emergent settings.
In response to the COVID-19 pandemic, the Biden administration recently announced its National Biodefense Strategy aimed at national preparedness for biological threats. The National Biodefense Strategy sets several targets for improved capabilities in order to respond to biologic threats – such as a pandemic – including "maintaining clinical trial infrastructure so that new trials can be launched within 14 days of medical countermeasure identification." On Oct. 28, the White House Office of Science & Technology Policy, in conjunction with the Office of the National Coordinator for Health Information Technology (ONC), issued a Request for Information on Data Collection for Emergency Clinical Trials and Interoperability Pilot (RFI), which seeks input on how to use interoperable technologies to facilitate the capture, collection and exchange of clinical trial data before and during an emergency. Based on the information requested, the agencies are likely building upon the groundwork laid by ONC's interoperability regulations to effectuate the goals set forth in the National Biodefense Strategy.
Operationalizing Protocol Distribution
In an effort to better prepare for large-scale research during a potential emergency, the agencies are seeking information on "how to best operationalize protocol distribution and data capture from a technical perspective." Specifically, the RFI requests input on technical strategies to distribute clinical trial protocols and capture data using application programming interfaces (APIs) based on common Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) before and during an emergency. The agencies are also seeking comment on how to effectuate the goals in a data capture pilot or demonstration project, which, if utilized, could form the basis for training sites and may strengthen the clinical trials framework.
OSTP and ONC are also seeking comment on facilitating a specific multistep use case where a government entity would oversee a clinical trial protocol conducted in another site setting with specific data collection, data exchange using APIs, data capture using an electronic case report form and data flows to a central data repository.
Leveraging ONC's Technical Framework in Clinical Trials Setting
The agencies believe that the eventual pilot or demonstration project would be supported by ONC's regulatory framework for the interoperability of electronic health records, including the development of the United States Core Data for Interoperability (USCDI) standard, FHIR-based APIs and Substitutable Medical Applications and Reusable Technologies (SMART) that are compatible with FHIR interfaces (referred to as "SMART on FHIR" APIs). The RFI is also seeking comment on how the government can leverage these standards and technologies to operationalize data capture in the near future (potentially within six-to twelve months of the close of comments to the RFI).
Specifically, the RFI is seeking comment on how the USCDI can be leveraged to support emergency clinical trial research, how HL7 FHIR-based APIs can be leveraged to support clinical trial research in pre-emergency and emergency phases, how SMART on FHIR APIs can be leveraged, such as through the creation of SMART on FHIR technologies that are portable across institutions, how the HL7 Clinical Decision Hooks specification could support clinical research, and how certain technologies can facilitate complex clinical studies involving the evaluation of investigational agents.
From a privacy and ethical standpoint, the RFI is seeking comment on how consent and de-identification can be appropriately managed in a central repository (or repositories made available to researchers from outside institutions). The RFI is also seeking comment on user interface, data element collection and the eventual support for research exchange purposes under the Trusted Exchange Framework, Common Agreement, which sets baseline interoperability standards for sharing clinical data.
Conclusion
Though it is in its early stages, the RFI could signal a regulatory and technological shift in how clinical trial data is shared between institutions and sites. If implemented, new technological capabilities could improve the capture and dissemination of clinical trial data across health organizations and settings in both emergent and non-emergent scenarios. Comments are due Dec. 27. We will continue to monitor and report significant rulemaking related to this RFI.
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