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- W2001299659 abstract "THERE IS GROWING AWARENESS THAT THE RESULTS OF randomized clinical trials might not apply in a straightforward way to individual patients, even those within the trial. Although randomization theoretically ensures the comparability of treatment groups overall, there remain important differences between individuals in each treatment group that can dramatically affect the likelihood of benefiting from or being harmed by a therapy. Averaging effects across such different patients can give misleading results to physicians who care for individual, not average, patients. The limitations of subgroup analyses—the conventional means for exploring differences in treatment effect based on patient characteristics—are well-appreciated. Because patients in trials, as in clinical practice, have many attributes that can affect the likelihood of treatment being beneficial or harmful, exploring each of these attributes “one variable at a time” (eg, male vs female, old vs young) risks spurious false-positive subgroup results from chance fluctuations. Furthermore, although patients have simultaneous multiple characteristics that can affect the likelihood of the outcome and the effect of therapy, one-variable-at-a-time comparisons are fundamentally limited because they compare groups that vary only on a single factor, usually resulting in the subgroups being more similar than different." @default.
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- W2001299659 date "2007-09-12" @default.
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- W2001299659 title "Limitations of Applying Summary Results of Clinical Trials to Individual Patients" @default.
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- W2001299659 doi "https://doi.org/10.1001/jama.298.10.1209" @default.
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