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Nov 18 -- OSTP extends comment period to January 27, 2023. https://www.federalregister.gov/d/2022-25166

Oct 28 -- The Office of Science and Technology Policy (OSTP) issues a Notice of Request for Information (RFI) on Data Collection for Emergency Clinical Trials and Interoperability Pilot. Interested persons and organizations are invited to submit comments on or before 5:00 p.m. ET on December 27, 2022.

Summary: As described in the recent RFI on Clinical Research Infrastructure and Emergency Clinical Trials, the White House Office of Science and Technology Policy (OSTP), in partnership with the National Security Council (NSC), is leading efforts to ensure that coordinated and large-scale clinical trials can be efficiently carried out across a range of institutions and sites as needed to address outbreaks of disease and other emergencies. In this RFI on Data Collection for Emergency Clinical Trials and Interoperability Pilot, issued in partnership with the Office of the National Coordinator for Health Information Technology (ONC), OSTP and ONC seek input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common application programming interfaces (APIs), in the pre-emergency phase as well as in emergency settings. One specific objective for this RFI is to gather information about whether there is value in a pilot or demonstration project to operationalize data capture in the near term, for example within 6-12 months of the close of comments on this RFI.
 
Background on emergency clinical trial research: OSTP (in partnership with the NSC and other Executive Office of the President components) is leading an initiative to enhance U.S. capacity to carry out clinical trials in emergency situations. This initiative is undertaken in accordance with the 2022 National Biodefense Strategy for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security and aligns with the goals of the American Pandemic Preparedness Plan (AP3).

In the recent RFI on Clinical Research Infrastructure and Emergency Clinical Trials, OSTP is seeking input on the emergency clinical trials effort generally, including U.S.-level governance models to support the emergency clinical trials effort. Governance functions might include determining when coordinated, large-scale clinical research is needed, including research on countermeasures, to address outbreaks of disease or other biological incidents. A further governance function might be to develop clinical trial protocols (in coordination with external stakeholders), which could range from relatively simple studies to more complex ones involving the evaluation of investigational agents. OSTP also seeks comment in the RFI on Emergency Clinical Trials on how emergency clinical trial data should be managed to facilitate researchers' access and analysis of results. One potential model would be the use of a centralized data repository and biorepository for specimens collected during trials.

In this RFI on Data Collection for Emergency Clinical Trials and Interoperability Pilot, to further prepare the U.S. clinical trials enterprise to carry out coordinated, potentially large-scale research protocols in an emergency setting, OSTP is seeking input on how best to operationalize protocol distribution and data capture from a technical perspective. Specifically, in this RFI we seek input on viable technical strategies to distribute clinical trial protocols and capture clinical trial data using common Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR®)-based APIs, in the pre-emergency phase as well as in an emergency setting. We seek comment on how to build towards both of these goals in a data capture pilot or demonstration project. This pilot, if implemented, could provide training for sites in underserved communities, thereby enlarging and strengthening the overall clinical trials infrastructure.

Desired use case: OSTP is still in the process of collecting information on governance models and other aspects of the emergency clinical trials initiative. For purposes of responding to this RFI, however, we would like responders to consider the following multi-step use case.

1. A U.S.-level governing entity would oversee development of a clinical trial protocol for broad distribution across clinical trial networks and sites.

2. Study sites would enroll participants in the trial (potentially using software mechanisms that can alert sites to potential subjects for a specific protocol in a manner that increases the diversity of trial populations). Sites would obtain appropriate e-consents and authorizations from participants.

3. Clinical trial data is typically sent to the trial sponsor though an electronic case report form (eCRF), which is the record of data that is required under the protocol to be captured for each trial participant. A data element in an eCRF is the smallest unit of observation for a particular subject.

4. The eCRFs would be transmitted electronically via common APIs to the sponsor.

5. The study site's health IT system would present the eCRF content to clinicians in a manner that expedites data collection and (ideally) fits within clinician workflows.

6. As the clinician obtains data elements to complete the eCRF, that data would be captured in the patient's electronic health record.

7. The clinical trial data would also be sent to a central data repository or small set of data repositories for researchers to analyze. It would be sent via common APIs so that researchers can easily interpret the eCRF data elements. Commercial cloud solutions are likely to house the data repository or repositories. Nonetheless, we would like a solution that would work across multiple cloud vendors.

For the purposes of this RFI, we are interested in the feasibility of all steps in the above hypothetical use case; we would also like input on how much of the use case could be operationalized in a pilot or demonstration project that might move forward in a timeframe of 6-12 months from the close of comments on this RFI.

ONC standards for interoperability: We believe that a pilot or demonstration project such as described above would be well supported by the regulatory and governance structure for interoperability of electronic health records (EHRs) that has been put in place by the Office of the National Coordinator for Health Information Technology (ONC). Among other initiatives, ONC is currently supporting development of the United States Core Data for Interoperability (USCDI) standard; the FHIR application programming interfaces (APIs); and Substitutable Medical Applications and Reusable Technologies (SMART) platform technologies that are compatible with FHIR interfaces and have given rise to a category of “SMART on FHIR” APIs. Certified health IT developers seeking certification on their Health IT Modules are currently working to meet various ONC certification criteria intended to improve data interoperability. For example, certified developers are required to implement certified API technology capable of patient and population services based on FHIR Release 4, the FHIR US Core Implementation Guide, and based on the HL7 FHIR® Bulk Data Access (Flat FHIR®) (v1.0.0: STU 1), August 22, 2019 Implementation Guide, by December 31, 2022.

In addition, ONC published the Trusted Exchange Framework, Common Agreement—Version 1, and QHIN Technical Framework—Version 1 on January 19, 2022. The overall goal of the Trusted Exchange Framework and Common Agreement (TEFCA) is to establish a universal floor for interoperability across the country. The Common Agreement will establish the infrastructure model and governing approach for users in different networks to securely share basic clinical information with each other—all under commonly agreed-to expectations and rules, and regardless of which network they happen to be in. Entities seeking to be designated as Qualified Health Information Networks (QHINs), per the Common Agreement, can apply for that designation on a voluntary basis. A QHIN is a network of organizations that work together to share health information. The goal of TEFCA is for QHINs to connect directly to each other to ensure interoperability between the networks they represent and to serve a wide range of end users.

The Common Agreement defines Exchange Purpose(s) as “the reason, as authorized by this Common Agreement including the Exchange Purposes SOP, for a Request, Use, Disclosure, or Response transmitted via QHIN-to-QHIN exchange as one step in the transmission.” Although research is not an authorized Exchange Purpose under the current version of the Common Agreement, it is a planned future Exchange Purpose, and responses to this RFI could inform how TEFCA might best support research in the future.

The implementation SOPs for Public Health and some other current Exchange Purposes, including Payment, Health Care Operations, and Government Benefits Determination, have not yet been developed. These SOPs will need to specify constraints, and at least some of the to-be-defined constraints are likely to be applicable to a future research-focused Exchange Purpose. Therefore, this RFI also seeks input on how TEFCA's Public Health Exchange Purpose Implementation SOP might be designed to enable public health authorities to answer questions that align with the activities described in this RFI.

More information on ONC data interoperability initiatives is available at https://www.healthIT.gov, and more specific information about TEFCA at https://www.healthit.gov/​TEFCA and https://rce.sequoiaproject.org/​.

OSTP invites input from all interested parties as outlined in the instructions. Respondents may provide information for one or as many topics below as they choose.

Our goal for this RFI is to support optimized data collection for clinical trials carried out across a range of institutions and sites, both in emergency settings and in the pre-emergency phase, under the use case described above. We also seek input specifically on the value of designing a pilot or demonstration project to operationalize data capture in the near term, for example within 6-12 months of the close of comments on this RFI. With those goals in mind, we request input on the following topics . . . .
 
FRN: https://www.federalregister.gov/d/2022-23489
OSTP blog (10.31.22): OSTP, in Partnership with ONC, Seeks Input on Optimizing Data Capture for Clinical Trials
https://www.whitehouse.gov/ostp/news-updates/2022/10/31/ostp-in-partnership-with-onc-seeks-input-on-optimizing-data-capture-for-clinical-trials/

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