May 10, 2010
The President of the MD Anderson Cancer Center, Dr. John Mendelsohn, summarizes the IOM report he chaired that listed recommendations for streamlining the NCI clinical cancer trial process and modernizing the trial designs.
In Part 1, Dr. Mendelsohn explains:
- What is the NCI (what agency does it fall under, its mission, etc)
· Some major advancements in cancer therapy made possible by NCI research
· Why pharma and biotech companies do not have an incentive to conduct trials that the NCI does
- What agencies the NCI collaborates with (ECOGs, private industry, etc)
In Part 2, Dr. Mendelsohn discusses the recommendations in the IOM report. Specifically:
- How the IOM report on changes to the NCI came about
- How the NCI can reduce redundant offices and consolidate
- What changes the FDA should make in terms of making a single “cancer” division
- What are “biorepositories” and how they should be implemented
- Are surrogate parameters, such as PFS, acceptable as endpoints?
In Part 3, Dr. Mendelsohn discusses:
- How biomarkers, such as KRAS or EGFR mutations, should be used in trials
- How the NCI investigators can be compensated better.
- What the AMA can do regarding CPT codes for experimental therapies
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