Sunday, September 6, 2009

Unexpected Risks of Clinical Research

This weekend I not only answered "collapsing variables" for Stats, but read a chapter from Clinical Research regarding research risk. The chapter was written by Dr. , a long-time NIH researcher, who ended up mired in controversy regarding experimental nucleoside antiviral agents during the dawn of one of the biggest scare of the twentieth century: HIV and AIDS.

The chapter was formulated and refined over a decade and is modeled after a research lecture given by Dr. at NIH after his experience with having his entire program shut down for over two years while the FDA, NIH leadership, the Institute of Medicine (IOM), and congress all had their own independent full blown investigations into the unfortunate deaths of patients enrolled in this experimental phase III trial for hepatitis B (HBV).

Wednesday: meet with the senior Navy adviser on my proposed research topics. With only three years to earn, the dissertation process starts right out of the gate in the first semester. The expectation is that you have your topic and are performing the field of inquiry before December. No fooling around at this pace.

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