Although the US Food and Drug Administration requires new drugs to undergo rigorous premarket clinical trials, new surgical procedures are not regulated and may become widely used with little evidence of their safety or efficacy. Despite wide recognition of a greater need for evidence in surgery, a variety of practical and philosophical challenges have hampered use of randomized trials to test these interventions.
Kuehn BM. Surgeons Continue to Debate Place of Randomized Trials of Surgical Procedures. JAMA. 2009;302(14):1513-1519. doi:10.1001/jama.2009.1455