Dr. Wells said he “might be willing to break even to get my foot in the door on a trial, or even make maybe just a little less of a profit.” And, he said, “If you take the Celebrex trial as an example, you get to answer some interesting questions.”
Dr. Fleischmann agreed that sometimes there are reasons to do a trial other than for money. “There are trials where we don't make money,” he said, “because there's an answer that we want to get.”
There's no right answer on how long to keep records after a trial. “A lot of companies will say 15 years,” Dr. Fleischmann said. But the Food and Drug Administration can ask to see the data at any point. He stores his records from clinical trials at Iron Mountain, and “the storage fee is actually part of the budget.”
He referred to a case from his own practice, in which the FDA performed an audit on a study 18 years after its completion. Since he still had the data, Dr. Fleisch-mann felt secure in asking what would have happened if he had not had the data. “We could send you to jail,” he was told.
Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen Inc., Centocor Inc., Genentech Inc., and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche Inc.
Dr. Wells disclosed that he is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb Co., Centocor, Genentech, and TAP Pharmaceutical Products Inc.