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Proposed Use Cases:
Use Case | Detail | Your name | Comments / Discussion |
|---|---|---|---|
Broaden description beyond EUA transitions. | Suggest broadening the description to include RWE to supplement 510(k)s or PMAs (reduce burden or help bridge studies, lots of examples that have got FDA approval this way) and RWE to support claims expansion (e.g. new specimen type) for 510(k) or PMA devices. | Gyan Penrose-Kafka | There are examples of using RWE to generate evidence that can go through EUA, but how is it envisioned that an IVD Data Hub makes this better, higher quality, etc.? |
Instrumentation and Ancillaries | what instrumentation an assay is run on, that would be really helpful. I am not sure it is possible to collate specimen collection kit/swab/collection device but I can see scenarios where that could help expand claims. | Gyan Penrose-Kafka | Data could come from LIDR or from the device itself…discussion in white paper about sourcing data |
Public Health Reporting | The ability for the organization that houses the data hub to be able to report results on behalf of laboratories to local, state and federal public health agencies | Rob Rae | |
Research | The ability to use the data hub data for clinical research | Rob Rae | |
Research | Use the data hub data for post-market surveillance (may also help with claims extension) or clinical utility studies | Yue Jin | |
Innovation | Site / patient identification for enrollment in clinical studies - supportive of increasing diversity in clinical trials | Nick Decker | |
infrastructure | enable a decentralized approach enabling local usage of the data hub (i.e. at the source of production) for local needs as well as global usage accros all sites using a CDM & vocabularies | Xavier Gansel | this may translate into a federated nature for the IVD data hub, associating lab data & some relevant patient data. |