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Clinical Trials & IDC Rates? David R. Fielder 08 Jul 2004 18:18 EST

We are interested in obtaining and sharing information on indirect cost rates as applied to industry sponsored clinical trials, at both university-based and independent academic medical centers.

As the regulatory burden and labor intensity of clinical trials increase
"covering costs" continues to be a losing battle.  Sponsors also seem to more
frequently be pushing back on indirect rates over 25%.

We aren't really trying to do a survey, but more seeking comments/advice re:

1.  How you set rates, particularly if above the "norm" of 25% - also is it a typical MTDC rate or otherwise?

2.  If you use a federal IDC rate, and how it may differ from your rate for lab-based research.

3.  What components of the typical clinical trial budget does the rate cover (i.e. does it apply to already burdened hospital ancillary services prices, etc.).

4.  What has been your experience with Pharma if your rate exceeds the 25% "norm".

5.  Are your MDs employees, or independent contractors (as ours are).

Off-line replies, or via listserve would all be greatly appreciated.

 Thanks,  David
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Mr. David R. Fielder                    tel: 415.600.1600
Vice President Research         fax: 415.600.1753
Research Institute                 email: xxxxxx@cooper.cpmc.org
California Pacific Medical Center  website: http://www.cpmc.org
2200 Webster Street,  Suite 514
San Francisco, CA 94115
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