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$450K Per Change

Protocol Amendment Costs

June 29, 2011

There is a noble tradition at the Drug Information Association (DIA) conferences. Presenters never speak of money. The assumption is that industry-sponsored research is so exalted that dollars and euros need never be mentioned. Rather, it would seem, large sponsored clinical trials are fueled by hugs and smiles. At this year’s DIA gathering, however, there was at least one session that departed from that tradition. That session discussed the real costs of changing clinical trials that are under way. The costs of protocol amendments, in both dollars and time, are yet another elephant in a crowded room of clinical trial elephants—chronic, apparently intractable issues. “Protocol amendments are a very large problem for our industry,” says Anne Cropp, executive director at Pfizer. Broad Issue She moderated the DIA session and was blunt about amendments. “They are our solution,” she said, “to poor protocol quality.” The session didn’t explore the origins of bad…more...

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