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Last Updated: 07/25/14

2009 BRN Symposium Workshop 2A:
Evidence-based protocols (9:30 am - 11:30 am)

Identifying the need for evidence-based protocols


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)


  • 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:

  1. How are evidence-based protocols developed?
  2. Which protocols are needed to advance the biospecimen sciences? Can they be prioritized?
  3. Which currently available cancer-related protocols need more evidence?
  4. Is there a method to rate protocols by “strength of evidence?”
Tentative Agenda: (times are approximate)
Time Session
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