Randomized clinical trials in surgical oncology.

Are randomized clinical trials needed to evaluate new therapies? Judging from the number of randomized trials which get published in medical journals, the answer seems to be unequivocally positive. No new drug may be put on the market without at least two randomized studies showing its benefit. In comparison, prospective, controlled and randomized studies are rather more sparse in the evaluation of new surgical approaches. Moreover, the kinds of trials that are performed to test new anti-cancer drugs may not provide an appropriate model to establish the worth of treatments given as adjuvant to surgery. This paper briefly discusses some reasons why trials should be more common in surgical oncology, and some ways in which they could be made more pertinent.