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201805 Clinical Research Track

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Track Name

Clinical Research

Submitting WG/Project/Implementer Group

Biopharma FHIR Project Group

Justification

This track will continue to evaluate use of FHIR for clinical research of new biopharmaceutical experimental treatments, seeking to advance the use of FHIR resources as eSource data used to pre-populate clinical research case report forms for both regulated and non-regulated clinical research. Plans for this connection include participation from at least 3 clinical data system implementers and pharmaceutical companies. 3 detailed use case scenarios will be proposed, 2 of which build on prior work at previous connectathons, and one exploring a new area for writing back with updates to clinical data from a clinical system. This work will inform development of profiles and IGs to support clinical research using FHIR, which will likely inform projects of the BR&R workgroup.

Clinical Research studies currently require the redundant entry of clinical data that already typically reside in Meaningful Use conformant EHR systems. EHR data represents original records in electronic format that can be used as eSource and directly imported into clinical research EDC databases so as to improve the quality and consistency of data between EHR and EDC systems and eliminate the need for redundant data entry. Establishing interoperability between EHR and EDC systems to streamline and modernize clinical investigations should improve data accuracy, patient safety, and clinical research efficiency. Given the extreme cost and extended time required for randomized clinical trials, it would be substantially better to utilize EHR source data to directly populate clinical trial databases wherever feasible. As stated in its May 2016 FDA draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” FDA “encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. . . Establishing interoperability between EHR and EDC systems to streamline and modernize clinical investigations should improve data accuracy, patient safety, and clinical research efficiency.”


Proposed Track Lead

Geoff Low, Medidata; Wayne Kubick, HL7

See Connectathon_Track_Lead_Responsibilities

Expected participants

Medidata, UCB, Parexel

Roles

FHIR Client

Support the sending from an EHR or patient device of clinical research study data: create, read, search and update to a clinical study database system.

FHIR Server

Supports a FHIR API which can respond to requests from a clinical research FHIR clinical research client.

Clinical Trial Designer

Identifies data relevant to research studies that may be collected from EHRs or SMART-on-FHIR devices. Sets up patient matching criteria and identifiers for ResearchStudy and ResearchSubject for a synthetic test study. Creates study database, mappings/interfaces, EDC case report forms with variable mappings to FHIR that will receive EHR patient data for clinical trial subjects. Generate updates from EDC to apply to the EHR.

Clinical Trial Designer

Clinical Trial Designer[edit] Identifies data relevant to research studies that may be collected from EHRs . Sets up patient matching criteria and identifiers for ResearchStudy and ResearchSubject for a synthetic test study. Creates study database, mappings/interfaces, EDC case report forms with variable mappings to FHIR that will receive EHR patient data for clinical trial subjects. Generate updates from EDC to send to the EHR for keeping EHR and study databases in sync.

Data Collector

Queries API to identify patients by Study and Subject identifiers to pull EHR data for demographics, medications, observation and Condition data that maps directly to variables on eCRF. Provides data generated by patients to add to study databases or EHRs.

Scenarios

Scenario 1: Create Research Study and Research Subject Resources

One of the limiting factors for uptake is a lack of realistic scenarios/examples for early adopters to be able to utilize for understanding the intended use. The outcome of this Scenario will be a set of example ResearchStudy and ResearchSubject JSON code blocks that can be incorporated into the published FHIR Standards.

Precondition:

1 or more FHIR servers with patient data suitable for inclusion in an Rheumatoid Arthritis trial have been identified and can be accessed.

Action:

a) Create a Draft ResearchStudy for a Sample Phase I Rheumatoid Arthritis (RA) Study with the following identifiers:

 •	Study Name: RA1234
 •	Primary Sponsor: Fixemup Pharma
 •	NCT ID: NCT039888888

b) Add the following inclusion criteria as follows:

 •	Female Participants aged 45 and greater
 •	History of RA
 •	Currently or previously taking Steroid-based medication for treatment of primary condition

c) Change the status of the Study from Draft to Active d) Create three ResearchSubject resources to enroll in Study RA1234

Success Criteria:

a) Three sample ResearchStudy resources b) Three sample ResearchSubject resources

Bonus point:

a) Take a sample clinicaltrials.gov Study XML document and represent using a ResearchStudy resource. b) Provide a gap list of elements in the Study XML not covered by the ResearchStudy

Scenario 2: Prepopulate eCRF from EHR with New or Updated Clinical Data

Action:

When new data is collected or existing data changed for a patient enrolled as a ResearchSubject in a ResearchStudy, new data will be made available to the clinical study database.

Precondition:

Subjects are registered for a study in the EHR. Data is changed in the EHR.

Success Criteria:

New or updated data is successfully imported into EDC.

Bonus point:

Identify potential Adverse Events from a Condition Resource.


Scenario 3: Submit Updated Clinical Data from Research Database to EHR

Action:

A proposed change to the EHR data is identified in the Research Database and is sent as a request to update the EHR for consistency.

Precondition:

The original record exists in both the EHR and EDC study database. One or more data points have been updated in the EDC database (presumably after generation of a query to the site).

Success Criteria:

The EHR received the updated data.

Bonus point:

The EHR is able to update the database with the corrected data.


TestScript(s)

Security and Privacy Considerations

OAuth will be used. Clinical Research scenarios require that access to patient identifying information be limited to the research site, so the use of the ResearchSubject anonymous identifier is critical.