New England Journal of Medicine
May 5, 2011  Vol. 364 No. 18
http://content.nejm.org/current.shtml

Perspective
Statistics in Medicine: Pragmatic Trials — Guides to Better Patient Care?
J.H. Ware, M.B. Hamel

[no abstract, first 100 words…]
Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients’ and clinicians’ actual questions about a given treatment. For example, placebo-controlled trials of a new migraine medication help to establish its efficacy, but they may not help clinicians and patients choose between the new medication and other available treatments. Moreover, since most randomized clinical trials are efficacy trials, researchers enroll a homogeneous patient population, define treatment regimens carefully and require that they be . . .