- Food and Drug Administration (FDA)
- Standardized Collection of Standardized Clinical Data
- Use of Clinical Data for Research
STATUS: Completed Project
The current information systems and data models that define both clinical care and clinical research data are disparate in many ways. Thus, using data from the electronic health record (EHR) and electronic data capture (EDC) systems necessitates a detailed understanding of each data source. Moreover, even data sources within the same database can have extensive differences in coding, schema, format, and usage. Given that clinical data are mostly collected through EHRs, a guideline or protocol for the use of health care data in clinical research and trials could be helpful to enable PCOR studies. In 2013, FDA published guidance on Electronic Source Data in Clinical Investigations, which provides recommendations on the capture, review, and retention of electronic data in FDA-regulated clinical trials. To provide a working example of the FDA’s recommended approach, FDA initiated the OneSource project, which provides a real world demonstration of their guidelines and commitment to EHR-to-EDC in clinical research environments.
PROJECT PURPOSE & GOALS
This project demonstrated an approach to collect data for clinical trials that populated an EDC system directly from an EHR system in an FDA-compliant way using the Retrieve Form for Data Capture (RFD) standard, HL7 Continuity of Care Document (CCD), Integrated Health Enterprise (IHE), FHIR®, and Clinical Data Interchange Standards Consortium (CDISC) standards. The demonstration involved a collaboration with the University of California at San Francisco (UCSF) as part of a phase 3 trial in breast cancer entitled “I-SPY 3 TRIAL” (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and moLecular 3). The I-SPY 3 study is a large-scale trial that used adaptive approaches to simultaneously test several drugs for the treatment of breast cancer using biomarkers and involving the collection of electronic patient reported outcomes (ePRO). PCOR stakeholders were provided with a cloud-based Health Insurance Portability and Accountability Act (HIPAA) - and 21 C.F.R. Part 11-compliant tool to seamlessly integrate into any EHR and EDC system. This tool enabled PCOR stakeholders (i.e., health care providers) to track patient data at the point of care in their EHRs.
Demonstrate an end-to-end, EHR-EDC, standards‑based technology solution for the capture and transmission of regulated clinical research data.
Assess the value of the standards-based technology solution processes for FDA inspection and reconstruction of clinical investigations.
Assess the impact of the standards-based technology solution on current processes at the sites, and on remote monitoring of the study.
Develop guidelines for future implementations in both health care and clinical research.
Provide recommendations for the improvement of existing standards and implementations including standards‑development organizations and structured data capture (SDC).
Develop a general framework (technologies, processes, policies, governance, and standards) for the use of electronic SDCs in regulated clinical trials.
PROJECT ACHIEVEMENTS & HIGHLIGHTS
The team performed a gap analysis between clinical data elements collected in a health care setting by EHRs versus clinical data elements required for regulated clinical research.
The project team developed publicly available metrics on concordance of EDC Case Report Forms (CRFs) with the UCSF EHR system to demonstrate an EHR to EDC standards-based technology solution for the capture and transmission of regulated clinical research data.
The team developed guidelines and recommendations for future source data capture implementations as well as recommendations to Standards Development Organizations (i.e. CDISC, HL7) to enhance their standards and implementations.
The project team created a general framework for electronic source data capture systems used in regulated clinical investigations and created EDC/ePRO platforms assessment criteria to support this framework.
The project team completed the evaluation of OpenClinica (an EDC vendor) as a future eSource EDC platform. CDISC plans to leverage UCSF findings from OneSource in their development of oncology clinical trial standards.
PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES
In 2019, the project team published a final report titled, “Source Data Capture from EHRS: Using Standardized Clinical Research Data.” The report includes the results of the gap analysis and guidelines for future source data capture. The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/OneSource_Final_Report.pdf.
Below is a list of ASPE-funded PCORTF projects that are related to this project
Development of Data Infrastructure for Use of EHRs in Comparative Effectiveness Research (ONC/NLM CDEs) - The ONC and NLM common data elements (CDE) project was developed to standardize the collection and exchange of data, i.e., CDEs. For the electronic Case Report Forms (eCRFS), the project developed the standards for the eCRF structure/template as well as the CDEs that were used with them. These forms were ‘extensible forms’ which means that they were developed in a high-level computer language. This computer language facilitates defining the form as a single, stand-alone object. Taken together, these two ONC/NLM CDE products make evident that the project fits the functionality of Standardized Collection of Standardized Data.