Project Goal:
Health care networks with well developed, integrated data systems are able to generate real-world data accepted by the FDA for regulatory submissions.
COVID RWE: Using SHIELD
MDIC recently released its Real-World Clinical Evidence Generation: Advancing Regulatory Science and Patient Access for In Vitro Diagnostics (IVDs) framework created collaboratively with representatives from FDA and IVD manufacturers. Another project, Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) has been working for years laying out the foundation for linking IVD test data to the laboratory information systems and then into the institutional EHR. The current coronavirus pandemic has many diagnostic tests in the marketplace that have Emergency Use Authorization (EUA) status which allows them on the market without a full FDA submission. This project will bring the IVD manufacturers, FDA, and hospitals together to use IVD Real-World Evidence (RWE) in regulatory systems.
Primary Stakeholders
- Federal Agencies: FDA, CDC
- IVD Manufacturers
- Healthcare Networks with well-developed, integrated data systems
IVD Manufacturers Interested (to date)
- Abbott
- Beckman Coulter
- Beckman Dickenson (BD)
- Cepheid
- Exact Sciences
- Freenome
- GRAIL Bio
- Hologic
- Illumina
- Now Dx
- Roche
- Thermo Fisher
Federal Agencies Involved (to date)
- BARDA
- CDC
- FDA | OHT7 Office on In Vitro Diagnostics and Radiological Health
Opportunity to educate on practical RWE use
Project Deliverables
What are the questions we need to answer?
- Common Data Fields/elements
- Study End Points
- Data Quality
- Cybersecurity
- Privacy concerns
- Questions we do not yet know to ask
Current as of September 30, 2020
