But trials that compare new treatments to placebo, with predictable results, do not aid physicians in making these decisions. Active-controlled trials, in contrast, benefit many parties. Experimental subjects benefit by being assured that everyone will receive at least arguably effective treatment. Doctors benefit by learning how competing therapies compare with one another in a controlled trial. Once the medication is approved, patients benefit because doctors can make more informed clinical choices based on the results of these studies.
Payers benefit because they can use such data to favor a cheaper, yet equally effective, drug.
As medical knowledge advances, there are increasingly few conditions for which no proven therapy exists. The market is thus being inundated with large numbers of medications that are not substantial advances on their predecessors. This makes the role of active-controlled trials all the more important for the future. While not the only source of the problem, it is clear that FDA policy is seen as a critical driving force behind the use of placebos, both because the agency often requires them for new drug approval, and because the FDA sets a standard for clinical trials that is adopted internationally, even in studies where drug approval is not an issue. So new drugs can be approved in the absence of placebo-controlled studies.