Personalized Medicine vs Guideline-Based Medicine
Published online
May 27, 2013
Two
philosophical approaches to the implementation of optimal health care
are emerging—the use of evidence-based guidelines and the application of
personalized (or “precision”) medicine. Even though both approaches
have important merits, they both also can present conflicting priorities
that must be reconciled before they can be best leveraged.
Evidence-based
guidelines are generated based on the body of clinical data available
for a particular question. The highest level of evidence assigned in a
guideline is based on multiple randomized controlled clinical trials. In
general, randomized clinical trials have specific inclusion and
exclusion criteria designed to represent a population broad enough and
sufficiently enriched to attain a requisite number of end points and
demonstrate a statistically and clinically significant difference in
outcome. Subgroup analyses (both those that are prespecified and other
post hoc analyses) are often performed to identify characteristics
within the study population that are associated with greater benefit
from the intervention, with no benefit, or even with harm. Yet these
analyses are accompanied by warnings that findings should be cautiously
interpreted.1
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