View the Full Request for Participation 23-MP1001

Scope:

Strategic Capacity of the Marketplace Envisioned in this Request for Participation

The NESTcc Marketplace, once constituted, will support NESTcc by providing strategic capacity in following areas:

• Data platform: providing a foundation for data gathering and curation, especially platforms that put the patient in the driver’s seat, to gather health data into one place and share with the device community
• Data sources: creating a national resource mirroring the experience of patient care in the United States and general experience of health throughout an individual’s life
• Data connectors: deliver continuity of care and experience between disparate data sources (e.g., via aggregation/ linkage) while maintaining patient privacy and protections
• Data science and research methodology: design and analysis expertise and experience necessary to obtain the epidemiologic, informatic and statistical rigor inherent in fitfor-purpose RWD analysis
• Analytic cores: conducting analyses of ingested data and/or packaging analytics for data sources to conduct analyses, ensuring rapid, valid, and verified analyses suitable for RWD research.

Eligibility:

This opportunity to become a partner in the NEST Marketplace is open to private-sector, nonprofit, and for-profit organizations, especially those with experience in medical device evidence generation methodologies and supporting infrastructure (e.g., governance, IT and security, using interoperability standards [via FHIR or CDM] to enhance collaboration and automation).

Details and Requirements:

Each respondent is encouraged to frame the response in terms of how your organization can participate in the marketplace to further the NESTcc goals. The proposal should be submitted in the form of a presentation (e.g., PowerPoint, Prezi, Canva Google Slides), not to exceed 40 slides, and should include a plan for development and implementing the following:

General Information Requested:

• Provide organization name, address, and contact details for any follow-up information.
• Provide a description of your organization and research or RWE offering(s).
• Provide a listing of publications using your offering(s) in the past 5 years.
• Provide an overview of the plans to augment or modify your RWE-related offering(s) for the next 5 years.
• Describe your experience with medical device-related RWE (or, more generally, with medical product research).
• Describe protections and practices in place at your organization to assure patient privacy for data at rest and in transit.
• Describe your practices for HIPAA compliance and GDPR compliance.

Specific Information Requested:

Applicants for inclusion as a partners in the Marketplace should demonstrate capacity in one or more of the following categories. All partners selected to be in the Marketplace should also demonstrate their ability to work with other partners to provide a seamless service and their experience working within the regulatory framework of the FDA.

1. Data Platform:

• Provide information about data capture available on your platform (e.g., overall and by geographic region, sex at birth, race/ethnicity, and socio-economic status, longitudinal data for at least 5 years)
• Describe the types of data your platform is capable of capturing (e.g., informed consent, patient reported outcomes, diagnostic test results, imaging etc.).
• Provide information about the access to your data platform (e.g., traceability, extraction outside of your platform, analysis conducted within your data platform?
• Provide examples of collaborations to conduct research using your data platform

2. Data Sources:

• Describe the size of data source(s) (e.g., current number of individuals with data available, overall, and by geographic region, sex at birth, race/Ethnicity, and socio-economic etc.) and setting (hospital, specialist clinic, general practitioner, home etc.) and the number of patients with at least 5 years of data available.
• Describe use of terminologies available in your data sources for diagnoses (e.g., International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]), procedures (e.g., Current Procedural Terminology [CPT]), medications (e.g., National Drug Codes [NDC]), and labs/diagnostics (e.g., Logical Observation Identifier Names and Codes [LOINC]), medical devices identification (e.g., UDI, make and model)
• Provide policies and procedures to ensure completeness, consistency, and accuracy of data collection and management.
• Describe use of common data models leveraged for research purposes and capabilities for data extraction outside of your data source.
• Describe data adjudication policies implemented in your data source(s)

3. Data Connectors:

• Provide information about linkage methodology, assessment of accuracy of linkage and validations studies
• Provide information about informed consent and patient privacy protection with linkages
• Describe how your services have been used for aggregation/ linkage (e.g., whether services have been used to link RWD from health systems, registries, claim organizations, medical device manufacturers).

4. Data Science and Research Methodology:

• Describe your capacity to refine study questions, develop protocols (including endpoints selection and length of follow up) and analytic plans for device studies and produce reports
• Provide your expertise in statistical/epidemiologic methods (e.g., analysis, combining extant RWD with clinical studies)
• Provide information about your expertise in the natural language processing / machine learning / artificial intelligence (NLP/ML/AI) design and conduct (e.g., develop algorithm/model to define specific variable).
• Illustrate your expertise to design and conduct validation studies for RWD study outcomes, study populations and key covariates or other data elements an develop reports
• Describe your experience in your organization to develop code lists (e.g., ICD10-CM, CPT, NDC, LOINC) and develop, refine, and provide justification for operational definitions of data elements within RWD.

5. Analytic Cores:

• Describe your capacity for data adjudication, extraction, transformation, and loading accuracy into your system
• Describe your expertise for prespecified statistical modules available for analysis of RWD, data exploration, data analyses and auditing
• Provide information about ability for leverage novel data models for multiple studies
• Describe processes to build/deploy/house/monitor/QC data collection (e.g., for abstraction in data validation)
• Describe processes for data democratization/visualization for researchers outside of your organization to see the data
• Submission Components

Organizations with expertise in one or more of the five areas defined above are invited to submit their proposals to join the NEST Marketplace by submitting their response using the form below.

View the Full Request for Participation 23-MP1001