Discussion Paper # 4, Stat 8801, Spring 2008

Read the papers available at

http://www.stat.umn.edu/~sandy/courses/8801/articles/FirstInManStudy.pdf
http://www.stat.umn.edu/~sandy/courses/8801/articles/GuineaPigging.pdf

The first of these papers is a report of a Royal Statistical Society working group that was formed after a particular ``first in man'' study ended in severe consequences for several otherwise healthy subjects (you might need to figure out what ``first in man'' means). The second paper, from a recent issue of the New Yorker, discusses patient recruitment for phase one clinical trials. These papers should provide the basis of a discussion on the ethics of this sort of research, and the role of statisticians in trials like these.

Discussion date for this paper is February 27.



S Weisberg
2008-02-11