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Workshop 2A: Evidence-based protocols (9:30 am – 11:30 am)
Identifying the need for evidence-based protocols
Chairs:
James Robb, M.D. (Consulting Pathologist, OBBR, NCI)
Max Robinowitz, M.D. (Senior Medical Officer, FDA Office of In Vitro Diagnostic Device Evaluation and Safety)
Objective:
- To define the minimum standards for the development of cancer-related evidence-based protocols.
- To identify and prioritize currently existing protocols that need an increased amount of scientific validation.
- To identify areas for protocol development.
Questions to be answered by this workshop:
- How are evidence-based protocols developed?
- Which protocols are needed to advance the biospecimen sciences? Can they be prioritized?
- Which currently available cancer-related protocols need more evidence?
- Is there a method to rate protocols by "strength of evidence"?
Tentative Agenda: (times are approximate) |
9:30 – 10:00 am |
CAP and Protocol Development
James Robb MD |
10:00 – 10:30 am |
The importance of biospecimen integrity to FDA regulation of in-vitro diagnostic devices
Max Robinowitz MD |
10:30 – 11:00 am |
Discussion and development of protocol development standards, interactive ice cube tray protocol prioritization
Workshop Participants |
11:00 - 11:15 am |
Session wrap-up, conclusions, next steps
Pick up lunch and proceed to other workshops |
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