- Food and Drug Administration (FDA)
- Linking of Clinical and Other Data for Research
- Collection of Participant Provided Information
STATUS: Active Project
Existing comparative effectiveness research (CER) often relies on data captured at the point of care, re-entered into clinical research systems, and then consolidated and transformed for the analysis and research purposes. The process is viewed as complex, labor-intensive, and expensive, as it requires extensive data validation and normalization to assure accurate and effective evaluation. As a result, both study designs and study infrastructure for generating and appraising real-world evidence (RWE) are often limited. To improve the capacity to study medical devices in real-world settings, the FDA Center for Devices and Radiological Health (CDRH) launched a series of strategic efforts to improve national capacity to study medical devices, leading to establishment of the National Medical Device System Planning Board and the National Medical Device Registry Task Force, which produced landmark reports that set the direction for the development of the National Evaluation System for health Technology (NEST) and establishment of the NEST Coordinating Center (NESTcc). FDA and its partners have invested significant resources into standing up a strategically Coordinated Registry Networks (CRN) infrastructure designed to facilitate the evolution of traditional registries into CRNs capable of producing relevant and reliable data sources as part of the evolving NEST. Coordinated by one of the NEST Data Partners, the Medical Device Epidemiology Network (MDEpiNet), the CRN Community of Practice ( CRN-COP) was established to promote registries maturity through harmonization of their minimum core data sets, commitment to incorporation of device identification, patient engagement throughout and by facilitating the linking of registries to other data sources. CRNs – COP established a community of stakeholders including patient, providers, manufacturers, EHR vendors, hospitals/integrated delivery networks, standards development organizations, researchers, government agencies, and others interested in working together to make system changes in an area of women’s health device safety and effectiveness.
The goal of this project is to strengthen the CRNs as a real-world data source for high quality, relevant, reliable, timely and actionable evidence to improve patient outcomes of medical devices, specifically for technologies affecting women’s health. This will be done by advancing their ability to capture standardized data, include patient generated data, and link their registry data to additional data sources. Capturing standardized data will streamline data collection and support exchange of data across therapies, patient populations and episodes of care. For example, by including unique device identifiers (UDIs) in the CRN minimum core data set, the CRNs become suitable for routinely studying device-specific questions; by including patient-generated data in the CRN, the PCOR community can link the patient experiences to clinical data sources, and regulators can identify how devices are performing for patients and identify patient-centric endpoints for future studies. Lastly, by linking registry data to additional data sources (such as claims submitted by providers to bill for medical services), patients and providers can have a more comprehensive understanding of long-term outcomes and adverse events associated with health technologies. Such strengthened infrastructure would lead to better evidence generation in general and be better suited to address the gender/sex specific differences in health technologies. This project also proposes continued support for the CRN- Community if Practice (COP), which is a partnership between the national registries (aspiring to be CRNs) capturing experiences of patients treated by medical device technologies in 12 clinical areas including, but not limited to: women’s health, cardiac, and vascular health. This collaborative initiative will provide an opportunity to collect structured, standardized, analysis-ready patient data at the point of care. Strengthening the CRN-COP and each individual CRN will result in a more strategic approach to addressing the needs of entire PCOR stakeholder community via harmonized and interoperable infrastructure and potentially allowing for more complex study designs.
PROJECT PURPOSE & GOALS
The project’s goal is to strengthen the CRNs as a national infrastructure for technology affecting women’s health through the following five objectives:
Advance the CRNs capacity for PCOR use in 12 clinical areas through their development in 7 areas (attributes): patient engagement, unique device identification, data quality, efficiency, governance, sustainability and fitness for use during the total product life cycle (TPLC).
Pilot test and refine the existing device-specific Fast Healthcare Interoperability Resources (FHIR) profiles (produced as part of the FY17 project - Developing a Strategically CRN for Women’s Health Technologies in an expanded set of three to five CRNs to demonstrate the capture and exchange of CRN data using FHIR.
Pilot test and refine the existing instrument for capturing patient reported outcomes to capture patient preferences in the End Stage Renal Disease registry) to evaluate scientifically valid data regarding patient uncertainty in accepting a variety of benefit/risk tradeoffs within a CRN.
Advance CRN capacity to produce linked data sets and combine heterogeneous data and develop machine learning techniques to validate the linked data sets.
- Develop a gender- and sex- specific outcome measure framework for devices and test it in the most mature CRNs (e.g., in orthopedics, vascular, cardiac, abdominal hernia and neurologic clinical areas).