Charlie,
Our clinical trials (clinical research) rate is federally negotiated and has been 28.5%MTDC. However, we have only been applying it to direct costs that are not already fully burdened (presumably) at "normal" medical center rates (although these seem to often be discounted to remain within sponsor total per-patient budget limits). We are starting to lean towards a flat rate of 25%TDC, at least for all corporate (for profit) sponsored trials. I believe this would be easier to manage and probably return more dollars and thus cover more of our actual total costs. Also, it is my experience that sponsors rarely question such a 25%TDC flat rate (maybe it is almost an industry standard?).
We do few federally sponsored trials, so such a policy would simply be more effective cost recovery by a non-profit (us) from for-profits (them). Also, the Feds have never complained about being "under-charged".
In any case, this whole issue is extremely important. There is a lot of misperception on the part of clinicians that clinical trials are a great way to "make money" (IMHO). In my experience, this is normally the case typically when there are hidden subsidies from the recipient institution, such as IDC recovery compromises or failure to account for and/or correctly apportion all costs, leaving a disproportionate share for the PI. In addition, simple market forces dictate that nationwide trials, where the sponsor is offering a relatively fixed per-patient fee, are forcing higher COL areas to compete with lower COL areas, usually to their detriment. Of course the other perspective, at least sometimes, is that premiums may be paid for unusual expertise, access to patients, and efficiencies of operation.
If we aren't careful, this process will emulate the more localized Managed Care healthcare economic crisis, with each of us competing to achieve the lowest cost (or at least the lowest fee) and trying to make up our losses with volume.
I look forward to receiving your summary of this data.
Thanks, David
> Date: Thu, 1 Feb 2001 10:36:06 -0500
> From: "Kaars, Charles" <xxxxxx@RESEARCH.BUFFALO.EDU>
> Subject: Clinical Trial F&A Rates
>
> Colleagues (especially colleagues at AAU Institutions):
>
> In what has become an annual rite for this group, I would appreciate
> it if you would let me know what your institution's F&A (indirect cost) rate
> is for clinical trials and against what base the rate is charged (i.e. TDC,
> MTDC).
> As has been the case for previous requestors of this data, I will
> compile it and make it available to all who are interested. ;-)
> Thanks.
>
> Charlie
>
> Charles Kaars
> Assistant Vice President
> xxxxxx@research.buffalo.edu
> voice:716-645-2977 ext. 101
> fax:716-645-3730
===================================================================
Mr. David R. Fielder tel: 415.600.1600
Vice President, Research fax: 415.600.1753
California Pacific Medical Center email: xxxxxx@cooper.cpmc.org
Research Institute website: http://www.cpmc.org
2340 Clay Street, 5th Floor
San Francisco, CA 94115
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