A federal investigation found evidence supporting a whistle-blower's claims, raising questions about methods at community research hospitals in the United States.
Two years after becoming vice president for research at the biggest hospital in this university town, Suzanne Stratton said she had finally seen enough.
She had clashed repeatedly with a doctor who oversaw the local patients enrolled in more than 130 federally sponsored cancer studies — work that the hospital promoted in local television advertisements but that Dr. Stratton, who has a Ph.D. in molecular biology, said was often putting patients and science at risk.
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Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.
His image is used temporarily, in good fun, and without permission.
The FDA has recently issued new rules that help clarify who is allowed to have access to investigational medications that are still in the testing phase.
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FDA Issues Draft Guidance on "IRB Contiinuing Review After Clinical Investigation Approval" This guidance is much more comprehensive for IRBs, investigators and sponsors than the current guidance document on the subject matter of continuing review from FDA.
Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.