It’s really hard to have a animal study fully represent the potential effects of a drug/medical device within a human. There are so many variables within a human that can drastically effect how the drug/medical device will respond or more importantly how those items will effect the body. In the case where unexpected results occur, there could be a chance that the clinical trial is stopped, if the results are unfavorable to the study. As luisa mentioned above, budget fluctuation can increase efforts to address unexpected results, and compensate patients that were effected. In addition, there should be a level or risk included into a budget to compensate potential negative effects that the new product could have on patients when the product is released into the market.