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Bridget M. Kuehn

JAMA. 2009;302(14):1513-1519.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Whether randomized clinical trials should be used to compare open and laparoscopic versions of procedures is a topic of debate among surgeons. (Photo credit: Alexey Averiyanov/iStockphoto.com)

Now, however, leaders in surgery are exploring collaborative ways to facilitate such trials and are examining alternative strategies for assessing surgical interventions.

CHALLENGES

Historically, clinicians have relied on case series and the expertise of well-known surgeons to assess new surgical interventions. Although this has often led to the development of useful procedures, in some instances the result . . . [Full Text of this Article]

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