Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional)

Recently FDA launched a series of strategic efforts designed to improve the national capacity to study use and impact of medical devices in the real-world setting. FDA is collaborating with medical device stakeholders to build the National Evaluation System for health Technology (NEST) NEST will support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) by leveraging clinical registries in addition to the other data sources such as electronic health records (EHRs), pharmacies, public and private claims, and patient-generated data.

Since in the world of medical devices today, clinical registries collect and maintain detailed, curated clinical data on millions of patients receiving diagnostics and treatments involving health technologies, they can provide critical infrastructure that can be used for a variety of analyses related to real-world patient care and outcomes. To address some of the inherent and modifiable limitations of the registries, the model of strategically Coordinated Registry Networks (CRNs) was recommended by the National Medical Device Registry Task Force (NMDRTF) and further developed by Medical Device Epidemiology Network (MDEpiNet).

Following the recommendations of the NMDRF, several CRNs have been rapidly developing. More recently MDEpiNet launched the CRN Community of Practice (COP), a partnership of national registries aspiring to evolve into CRNs, that engages a wide variety of stakeholders to ensure that high value data is generated by CRNs including patient organizations, health care providers, regulators, payors, health services researchers, health technology manufacturers, software vendors, health exchanges and local, state, national and international government agencies and could also be used in social determinants of health and other local and state initiatives. This learning community, coordinated by MDEpiNet Coordinating Center (MDEpiNetcc), uniquely integrates multi-stakeholder's views and patient perspectives with harmonization and interoperability to address an important unmet need in the country, especially for conducting research on conditions and treatments that though clinically valuable, require continued evaluation of safety and effectiveness evidence as it evolves throughout the total product life cycle.

The main goal of this FOA is to advance infrastructure and methodology research to promote evolution of traditional registries into mature CRNs contributing a reliable, relevant and timely data on health technologies.

Specific Aims are:

(1) Facilitate coordination and maturation of Coordinated Registry Networks (CRN) Community of Practice;

(2) Develop and test drive novel methods in CRN science and surveillance by leveraging big data analytics;

(3) Augment CRNs by linking registries to other data sources (including administrative claims, electronic health records, patient generated data, and other available data sources;

(4) Collaborate with NEST partners and others to advance capacity of FDA to address complex health technology-related questions.

This will result in a more strategic approach to addressing the needs of the entire patient-centered medical device ecosystem, via harmonized and interoperable infrastructure that will allow for more complex study designs and analyses. 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 Identification (UDI) in the CRN minimum core data set, the CRNs become suitable for routinely studying device-specific questions; by including patient-generated data in CRN, the research 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; and by linking registry data to additional data sources (such as medical 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 that are important for reaching informed decisions.

All applications developed to address this announcement should consider the following points:

1. The existing CRN Community of Practice (COP) should continue to support transparency such that patients, physicians, hospitals, insurers, medical device industry, and regulatory bodies will have access to and be able to replicate any given analysis;

2. Applications should leverage the existing partnerships to advance data access and availability to all stakeholders and partners, including FDA (for research purposes as well as for Total Product Life Cycle evaluation);

3. Applications should include details on how patient privacy and data security will be established and maintained;

4. Applications should incorporate use of Unique Device Identification (UDI) to allow for adequate tracking and investigation into potential postmarket signals;

5. The methods and infrastructure systems developed should be capable of being applied more broadly across the medical device landscape;

6. Methodology and infrastructure development efforts should address the needs of multiple CRNs and their stakeholders across clinical areas; and

7. The scientific plan for developing the CRNs should be accompanied by a plan or framework for establishing a sustainable partnership business infrastructure to allow for substantial national or international coverage over an extended period.