For the results of randomized controlled clinical trials (RCTs) and
related meta-analyses to be useful in practice, they must be relevant
to a definable group of patients in a particular clinical setting. To
the extent this is so, we say that the trial is generalizable or
externally valid. Although concern about the generalizability of the
results of RCTs is often discussed, there are few examples of methods
for assessing the generalizability of clinical trial data. In this
paper, we describe and illustrate an approach for making what we call
generalizability judgments and illustrate the approach in the context
of a case study of the risk of suicidality among pediatric
antidepressant users.
Keywords: External Validity; FDA; Meta-analysis; Randomized Controlled
Clinical Trials; Youth Risk Behavior Survey