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Clinical Trials Conflict of Interest Question David R. Fielder 25 Jan 1999 20:01 EST

Is it OK for an MD to conduct a clinical trial (drug or device) as the PI
and own shares in the sponsor company, as long as there is prior disclosure
and evaluation/review of that relationship?  I have been under the
impression that this is something to be avoided almost at "all costs", but
am being told not necessarily so.  It may be that it's all a judgement call
based on significance to company direction, % of shares owned, multi-site
trial etc.  For example (may be a worst case), what if the PI was also the
CEO of the sponsoring corporation?  This latter example gets into
self-funding of research, another interesting area I expect.

 Would appreciate any specific references/regulations available.

 Thanks, David
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Mr. David R. Fielder                    tel: 415.561.1600
Vice President, Research                fax: 415.561.1753
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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