Dr. Wells observed that there are bound to be differences in perspective between physicians working in large group practices and those working in solo practices; between someone who has done "tons of clinical trials in a huge research group and somebody who is just essentially starting."
Noting that he might be in a somewhat different position from Dr. Fleischmann, who has done many trials, Dr. Wells said that 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 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 is no correct answer on how long to keep records after a trial. "A lot of companies will say 15 years. That's the usual," Dr. Fleischmann said. However, the Food and Drug Administration has the ability to go back and look at the data from a study at any point in time, he said.
"We keep them forever," he said, adding that he stores his records at Iron Mountain and the storage fee is part of the budget.
Dr. Fleischmann disclosed the following relationships with Abbott Laboratories, Amgen, Centocor, Genentech, and Wyeth: speakers bureau, consultant/adviser, and research grants. He also is on the speakers bureau for Hoffmann-La Roche. Dr. Wells is a consultant/adviser for Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and TAP Pharmaceutical Products.