Difference between revisions of "201805 Clinical Research Track"
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<!-- Provide a description of each task --> | <!-- Provide a description of each task --> | ||
| − | ===Scenario 3: | + | ===Scenario 3: 3. Investigate the AdverseEvent Resource === |
| − | + | ||
| − | + | The AdverseEvent resource is a draft resource in the FHIR standard. It presents a useful resource for clinical investigations; the semantics of an Adverse Event in a clinical study are such that it can be difficult to align with other resources - examples of possible mappings have included AllergyIntolerance, Condition (Problem), ClinicalImpression, DetectedIssue, DiagnosticReport. | |
| + | |||
| + | Use of the AdverseEvent resource will be a useful mechanism for the standardized representation of Adverse Event data for the purposes of exchange (and reporting) | ||
| + | |||
:Precondition: <!-- What setup is required prior to executing this step? --> | :Precondition: <!-- What setup is required prior to executing this step? --> | ||
| − | + | a) An EHR system supporting the AdverseEvent Resource | |
| + | b) An EHR system with Patient Data that may be associated with an AdverseEvent | ||
| + | :Action: | ||
| + | a) Construct an AdverseEvent Resource for a sample non-Serious Adverse Event | ||
| + | b) Construct an AdverseEvent Resource for a sample serious Adverse Event | ||
| + | |||
:Success Criteria: <!-- How will the participants know if the test was successful? --> | :Success Criteria: <!-- How will the participants know if the test was successful? --> | ||
| − | + | a) Two sample AdverseEvent resources are provided | |
:Bonus point: <!-- Any additional complexity to make the scenario more challenging --> | :Bonus point: <!-- Any additional complexity to make the scenario more challenging --> | ||
| − | + | a) Map a sample ICG E2B message structure or a CDISC AE record to an AdverseEvent resource | |
| − | |||
| − | |||
==TestScript(s)== | ==TestScript(s)== | ||
Revision as of 20:35, 3 April 2018
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:
Creation of Three sample ResearchStudy resources and 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: 3. Investigate the AdverseEvent Resource
The AdverseEvent resource is a draft resource in the FHIR standard. It presents a useful resource for clinical investigations; the semantics of an Adverse Event in a clinical study are such that it can be difficult to align with other resources - examples of possible mappings have included AllergyIntolerance, Condition (Problem), ClinicalImpression, DetectedIssue, DiagnosticReport.
Use of the AdverseEvent resource will be a useful mechanism for the standardized representation of Adverse Event data for the purposes of exchange (and reporting)
- Precondition:
a) An EHR system supporting the AdverseEvent Resource b) An EHR system with Patient Data that may be associated with an AdverseEvent
- Action:
a) Construct an AdverseEvent Resource for a sample non-Serious Adverse Event b) Construct an AdverseEvent Resource for a sample serious Adverse Event
- Success Criteria:
a) Two sample AdverseEvent resources are provided
- Bonus point:
a) Map a sample ICG E2B message structure or a CDISC AE record to an AdverseEvent resource
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.
