At the University of Rochester, we presently use a 25% TDC rate
for industrially-sponsored clinical trials. Our Federal negotiated
rate is 57% MTDC. Our clinical trial rate has been really been a
reflection of what others are charging.
However, we are currently looking at revamping our approach to
clinical trial rates regardless of sponsor (feds or company) by
basing them on the protocol involved. We are thinking that we
will apply our off-campus research rate (28% MTDC) to all trials where
we are merely a participant following a predefined protocol. Where
we are the coordinator of a multi-center trial or where we have
done extensive development of the protocol or the like, we will
apply either our on campus research rate (57% MTDC) or a TDC rate
derived from our 57% rate. The change results from our concern of
inequity in federal trial rates where we charge our 57% MTDC rate.
We believe that we may have some audit exposure even though an
informal study we conducted shows that in most instances there is
very little recovery difference between federal and nonfederal trials.
On another note, as a newcomer to this group, it would be most
helpful to me if folks could identify their institution as its
very difficult to tell from the computer address where people are
from. I don't know if this has been a subject on this bb before,
but I'd appreciate it.
Jane Youngers, Director
Office of Research and Project Administration
University of Rochester
telephone: 716-275-5373
email: xxxxxx@mvs.cc.rochester.edu