Memorial Sloan Kettering Cancer Center (MSK) has streamlined the cancer clinical trial data exchange for trial sponsors. Typically, clinical research coordinators (CRCs) are responsible for manually extracting and entering data into sponsor electronic data capture systems (EDCs), costing them time and resources.
To alleviate this burden for CRCs, the Clinical Research Informatics and Technology (CRIT) department developed a process that electronically pulled trial data from various source systems within MSK to generate flat files that could be transferred to sponsors. While this resulted in meeting success metrics related to data latency, transcription errors and queries, and reduced time and effort for CRCs, CRIT absorbed the responsibility of managing variability across sponsors.
HL7-FHIR for Cancer Clinical Trial Data
To mitigate problems arising from variability across sponsors, CRIT has developed a solution for exposing data through Health Level Seven International Fast Healthcare Interoperability Resources (HL7-FHIR®) RESTful APIs that improve scalability and promote interoperability.
Our APIs conform to the secure standards of representational state transfer architectural style (REST). HL7-FHIR RESTful APIs represent a new standard for direct healthcare data extraction and exchange that:
- Provides a common data structure for each healthcare entity
- Uses modern web architecture for securely sharing data
- Allows sponsors to pull data on demand
This solution enables quicker clinical decision making and accelerates the rate at which new drugs come to market, ultimately improving outcomes for patients in the future.
MSK allows pre-approved sponsors to securely access and retrieve clinical data on demand from its HL7-FHIR Blaze API. Learn more about developer documentation and requirements.
For additional reference, read our peer-reviewed journal article, educational presentation, and summary PDF:
- Buckley M, Vattikola A, Maniar R, Dai H. Direct Data Extraction and Exchange of Local Labs for Clinical Research Protocols: A Partnership with Sites, Biopharmaceutical Firms, and Clinical Research Organizations. J Soc Clin Data Manag. 2021;1(1).
- Direct Data Extraction and Exchange of Local Labs for Clinical Research Protocols: A Partnership with Sites, Biopharmaceutical Firms, and Clinical Research Organizations.
- MSK eSource Transfers Summary: Flat File Direct Data Exchange (DDE) and HL7 FHIR API.
Frequently Asked Questions
What data domains can the HL7-FHIR API solution manage?
Our current production implementation can expose adverse events, demographics, laboratory results, and vital signs. Medication and response data will be available in the near future.
What steps are required to receive data electronically?
MSK’s clinical research operation and IT staff, in collaboration with sponsors, will first agree on a study and select a data transfer method: either via flat file or our preferred method, through HL7-FHIR APIs. After that, a data transfer specification (DTS) is drafted to document the visits and data requirements that need to be mapped for the protocol, and our protocol staff are trained on how to manage and review the data. For the flat file route, an additional step is required to set up an sFTP server. For the FHIR API route, we would generate a a client ID and secret, which are needed for generating a session token. The token would be passed in the headers of the API calls.
Is the HL7-FHIR API solution suitable to apply in an ongoing study? Should we start with a pilot?
Technically, it is possible to apply the solution to an already ongoing study, but there needs to be a clear delineation of when manual entry stops and when automated data submissions take over to avoid confusion for our staff. We recommend starting with a pilot but would work with you to select an appropriate study.
What are the contractual implications included in the Clinical Trial Agreement?
The Clinical Trial Agreements typically state the responsibility to provide the data but not how. We use our DTS as a handshake agreement to provide the details of the data exchange between all parties.
Do you have data presentation examples?
For the HL7-FHIR APIs, data is returned as a JSON response whereas the flat file submissions can be text (comma delimited, tab delimited, etc.) or Excel file format. We can provide actual examples of formatting upon request.
Interested in leveraging our capabilities for a research study conducted at MSK? Email [email protected] with your organization name and study number for more information.