Notice2022-23489
Request for Information on Data Collection for Emergency Clinical Trials and Interoperability Pilot
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Published
October 28, 2022
Issuing agencies
Science and Technology Policy Office
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 208 (Friday, October 28, 2022)</title>
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[Federal Register Volume 87, Number 208 (Friday, October 28, 2022)]
[Notices]
[Pages 65259-65262]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23489]
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OFFICE SCIENCE AND TECHNOLOGY POLICY
Request for Information on Data Collection for Emergency Clinical
Trials and Interoperability Pilot
AGENCY: Office of Science and Technology Policy (OSTP).
ACTION: Notice of Request for Information (RFI) on Data Collection for
Emergency Clinical Trials and Interoperability Pilot.
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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.
DATES: Interested persons and organizations are invited to submit
comments on or before 5:00 p.m. ET on December 27, 2022.
ADDRESSES: Interested individuals and organizations should submit
comments electronically to <a href="/cdn-cgi/l/email-protection#f591948194969a99999096819c9a9b939a8796999c9b9c96949981879c949986b59a868185db909a85db929a83"><span class="__cf_email__" data-cfemail="d5b1b4a1b4b6bab9b9b0b6a1bcbabbb3baa7b6b9bcbbbcb6b4b9a1a7bcb4b9a695baa6a1a5fbb0baa5fbb2baa3">[email protected]</span></a>
and include ``Data Collection for Clinical Trials RFI'' in the subject
line of the email. Due to time constraints, mailed paper submissions
will not be accepted, and electronic submissions received after the
deadline cannot be ensured to be incorporated or taken into
consideration.
Instructions
Response to this RFI is voluntary. Each responding entity
(individual or organization) is requested to submit only one response.
Please feel free to respond to one or as many prompts as you choose.
Please be concise with your submissions, which must not exceed 10
pages in 12-point or larger font, with a page number on each page.
Responses should include the name of the person(s) or organization(s)
filing the comment.
OSTP invites input from all stakeholders including members of the
public, representing all backgrounds and perspectives. In particular,
OSTP is interested in input from health information technology (health
IT) companies, app developers, clinical trial designers, and users of
health IT products. Please indicate which of these stakeholder types,
or what other description, best fits you as a respondent. If a comment
is submitted on behalf of an organization, the individual respondent's
role in the organization may also be provided on a voluntary basis.
Comments containing references, studies, research, and other
empirical data that are not widely published should include copies or
electronic links of the referenced materials. No business proprietary
information, copyrighted information, or personally identifiable
information should be submitted in response to this RFI. Please be
aware that comments submitted in response to this RFI may be posted on
OSTP's website or otherwise released publicly.
In accordance with FAR 15.202(3), responses to this notice are not
offers and cannot be accepted by the Federal
[[Page 65260]]
Government to form a binding contract. Additionally, those submitting
responses are solely responsible for all expenses associated with
response preparation.
FOR FURTHER INFORMATION CONTACT: For additional information, please
direct questions to Grail Sipes at 202-456-4444 or
<a href="/cdn-cgi/l/email-protection#81e5e0f5e0e2eeedede4e2f5e8eeefe7eef3e2ede8efe8e2e0edf5f3e8e0edf2c1eef2f5f1afe4eef1afe6eef7"><span class="__cf_email__" data-cfemail="6501041104060a09090006110c0a0b030a1706090c0b0c06040911170c040916250a1611154b000a154b020a13">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
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 \1\ and aligns with the goals of the
American Pandemic Preparedness Plan (AP3).\2\
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\1\ 2022 National Biodefense Strategy for Countering Biological
Threats, Enhancing Pandemic Preparedness, and Achieving Global
Health Security (October 2022), section 4.1.4.
\2\ First Annual Report on Progress Towards Implementation of
the American Pandemic Preparedness Plan (September 2022), at 22-23.
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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[supreg])-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[supreg] Bulk Data
Access (Flat FHIR[supreg]) (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),\3\ per
the
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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.
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\3\ The Common Agreement defines a QHIN as ``to the extent
permitted by applicable Standard Operating Procedure(s) (SOP(s)), a
Health Information Network that is a U.S. Entity that has been
Designated by the RCE and is a party to the Common Agreement
countersigned by the RCE.'' See Common Agreement for Nationwide
Health Information Interoperability Version 1, at 10, 6 (Jan. 2022),
<a href="https://www.healthit.gov/sites/default/files/page/2022-">https://www.healthit.gov/sites/default/files/page/2022-</a>.
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The Common Agreement defines Exchange Purpose(s) \4\ as ``the
reason, as authorized by this Common Agreement including the Exchange
Purposes SOP \5\, 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.
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\4\ See Common Agreement for Nationwide Health Information
Interoperability Version 1, at 6 (Jan. 2022), <a href="https://www.healthit.gov/sites/default/files/page/2022-">https://www.healthit.gov/sites/default/files/page/2022-</a>.
\5\ The current version of the TEFCA ``Standard Operating
Procedure: Exchange Purposes'' specifies that authorized Exchange
Purposes under the Common Agreement and that SOP are: Treatment,
Payment, Health Care Operations, Public Health, Government Benefits
Determination, and Individual Access Services.
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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 <a href="https://www.healthIT.gov">https://www.healthIT.gov</a>, and more specific information
about TEFCA at <a href="https://www.healthit.gov/TEFCA">https://www.healthit.gov/TEFCA</a> and <a href="https://rce.sequoiaproject.org/">https://rce.sequoiaproject.org/</a>.
Information Requested: 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:
1. United States Core Data for Interoperability (USCDI). We seek
input on how U.S. Government and external stakeholders might leverage
USCDI and future extensions of USCDI standards (such as USCDI+, an
extension that supports federal partner program-specific requirements)
to support emergency clinical trial research. It would also be helpful
to receive comment on areas in which additional extensions might be
necessary.
2. HL7 FHIR APIs. We seek comment on how U.S. Government and
external stakeholders might leverage FHIR APIs to support research in
emergency settings as well as in the pre-emergency phase, and in what
areas further advances might be needed. Specific topics in this
connection include:
a. Use of an API that supports FHIR Bulk Data Access to support
clinical research; whether bulk data exports from EHR systems can be
used to support certain clinical trial protocols.
b. Use of the FHIR Questionnaire and QuestionnaireResponse
resources to support clinical research.
3. SMART on FHIR APIs: We seek input on how U.S. Government and
external stakeholders might leverage SMART on FHIR APIs, and in what
areas further extensions might be needed. It would be helpful to
receive comments on:
a. The most promising ways to create SMART on FHIR technologies
that are portable across different institutions and EHR systems, but
also provide adequate functionality to support emergency clinical trial
research.
b. Whether the portability of SMART on FHIR tools provides a way to
reach institutions and sites that have limited information technology
resources; any promising ways to use SMART on FHIR to expand clinical
research into underserved settings.
4. Clinical Decision Support (CDS) Hooks: We seek comments on how
the HL7 CDS Hooks specification might be used to support clinical
research, for example by creating prompts within the practitioner
workflow during interaction with patients; and any advances that might
be needed to support the use case described above.
5. Operationalizing protocols of varying complexity. As noted
above, emergency clinical trial designs could range from relatively
simple protocols to more complex studies involving the evaluation of
investigational agents. We would appreciate comments on the following
topics:
a. Whether any of the tools described above might be particularly
well suited for certain types of studies.
b. For example,
i. Whether a bulk FHIR API export could be used to gather data for
a simple trial protocol that is relatively close to the standard of
care for a particular condition.
ii. Whether a FHIR Questionnaire/QuestionnaireResponse or a SMART
on FHIR form would be useful in capturing data for a more complex
protocol, such as one that involves an investigational agent.
c. Any technical limitations that we should be aware of regarding
use of the above tools to operationalize clinical trial protocols.
6. Consent, deidentification, return of results. The use case in
this RFI contemplates that data would be managed through a central
repository or repositories and made available to researchers beyond a
patient's home institution.
a. In light of this, we seek comment on how the tools described
above can be used to obtain, collect and/or manage any required
informed consents and/or authorizations from patients or individuals in
accordance with applicable regulations.
b. We also seek input on what additional capabilities would be
required to deidentify or otherwise manage protected health
information. It would be helpful to receive comments on which
deidentification and protection approaches are sufficiently mature to
support a pilot effort in the near term.
c. Ideally, patient authorization would allow clinical trial data
to be used for additional research beyond the original study. We would
appreciate input on how the content collected for consent and
authorization as well as the interfaces with deidentification
technologies should be designed to enable flexible and responsible
reuse of clinical trial data.
d. We seek comment on any technical capabilities that could support
return of results to study sites or participants, where appropriate.
e. We seek comment on any regulatory or ethical guidelines that are
relevant to patients' consents and authorizations under the use case
described in this RFI, and on ways in
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which technical solutions might help ensure adherence to applicable
regulatory or ethical guidelines.
7. User interface and experience. With all of the above
technologies, we seek input on:
a. The best way to optimize the experience of health care
providers, administrators, and other users, so as to maximize the
utility and uptake of the product.
b. To the extent a particular form, app or other tool requires
input from a health care provider or other user, the best ways to
increase the likelihood that users will actually provide that input. It
would be helpful to receive comments on methods that are available for
completing empty fields after the fact, or otherwise managing any
missing data.
c. For clinicians and health IT users: what existing tools, apps,
or processes you have found most usable and why.
8. Capturing data elements required for clinical trial protocols.
a. We seek comment on the most promising technical approaches that
would leverage common APIs to translate a particular clinical trial's
data elements into data elements captured by user-facing tools (e.g.,
FHIR Questionnaire feeding into a SMART on FHIR form or application).
b. If a tool such as a FHIR Questionnaire, FHIR
QuestionnaireResponse, or SMART form or app is used to capture required
data elements in this way, we seek comment on whether that creates an
effective method for ``pushing out'' a research protocol to
investigators and sites.
c. It would be helpful to receive comments on how best to ensure
compliance with regulatory requirements for eCRFs when designing
interfaces for data capture.
9. TEFCA and QHINs. As noted above, TEFCA is in the implementation
phase at this time. In the future, the TEFCA QHINs are expected to
support implementation of the FHIR APIs (see the ONC Recognized
Coordinating Entity's January 2022 FHIR Roadmap for TEFCA Exchange
\6\). We would appreciate comment on the opportunities and challenges
regarding development of API implementations toward the use case
described above, particularly given the current status of TEFCA and
QHIN participation. Specific topics in this connection include the
following:
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\6\ <a href="https://rce.sequoiaproject.org/three-year-fhir-roadmap-for-tefca/">https://rce.sequoiaproject.org/three-year-fhir-roadmap-for-tefca/</a>.
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a. Certain policy and/or technical constraints will need to be
specified for currently authorized Exchange Purposes under the Common
Agreement (e.g., Public Health). We seek comment on which of these
constraints will also be applicable to a future research-focused
Exchange Purpose.
b. Opportunities that may exist for using the initially authorized
Exchange Purposes to accomplish the use case described in this RFI.
c. How the Public Health Exchange Purpose could be used to advance
the goals of this RFI; what aspects of the use case described above
might fall within the scope of the Public Health Exchange Purpose.
d. How a future research-focused Exchange Purpose could be
structured to advance the goals of this RFI.
e. Other opportunities or constraints related to TEFCA that should
be considered with regard to this RFI.
10. Emerging technologies. We welcome comments on any future
technological developments we should anticipate. Relevant technical
developments include but are not limited to differential privacy;
federated machine learning; other technologies referenced in the recent
OSTP RFI related to privacy-enhancing technologies (PET) (see Federal
Register: Request for Information on Advancing Privacy-Enhancing
Technologies); and technologies outside of the PET space. Specific
topics in this area include:
a. How future technologies might affect the use case and underlying
assumptions laid out in this RFI.
b. How future technologies might change the nature of the software
architecture, data architecture, or potential data collection solutions
for clinical trials.
11. Pilot or demonstration project. We seek comment on how the U.S.
Government can best work with external stakeholders and developers to
develop a pilot or demonstration project that will operationalize
clinical trial data capture and serve as a basis and model for data
collection in the event of an emergency. This pilot or demonstration
project could also potentially support clinical research in the pre-
emergency phase. Specific topics include:
a. Whether data can be managed through a central repository or
small set of central data repositories; options for cloud-based data
storage.
b. Technical options that might hold promise in the short term to
enable researchers from diverse locations to analyze the data collected
from multiple clinical trial sites. We also seek comment on any
additional options that should be considered in the long term.
c. Whether any parts of the pilot would be appropriately supported
as
i. A demonstration project with commercial partnership.
ii. A public-private partnership.
iii. An agency-funded program.
12. Specific commercial capabilities. Commenters who are developing
a technology or product that might be relevant to any of the topics set
forth above are welcome to include a description of that product.
Comments about a specific technology or product should be limited to
three pages or less.
Dated: October 25, 2022.
Stacy Murphy,
Operations Manager.
[FR Doc. 2022-23489 Filed 10-27-22; 8:45 am]
BILLING CODE 3270-F1-P
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