Researchers have evolved from the 1970s, when any doctor who wanted to fiddle with something could pretty much do it, to a year 2000 in which if a doctor changes the size of a urological catheter in a standard procedure for more than three or four people and writes a case series in a journal, he risks censure for doing human subjects research without the approval of an Institutional Review Board.

Mr. Loarie responded by noting that his company had started its investigational work in Brazil and done further research in Mexico and in Europe, and he had yet to meet a doctor in any of those countries who was unconcerned about harm to a patient. Integrity of clinical research is not unique to the United States. These doctors have practices. They have reputations and they demand a lot from Loarie’s company before they will do anything.

Dr. Alpert brought the discussion to a close by noting that FDA actually addressed the issue of tinkering during clinical trials. Devices are allowed to evolve during clinical trials, despite the implication yesterday that nothing can be changed. During an IDE, a product can, in fact, evolve appropriately as long as impact of the changes on the data is taken into consideration, that is, the ability to pool data to understand what that technology or that technological change or the tinkering or the modification of manufacturing has accomplished.

Obviously, communication is very important, but there is opportunity for products to evolve during clinical trials and not be absolutely frozen. There are formulation issues in dealing with drugs, and there are changes in device design that can, in fact, render the data non-poolable. That must be considered as one goes forward but one can, in fact, evolve.

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