title: Generalizing from clinical trial data: a case study. The risk of suicidality among pediatric antidepressant users.
abstract: 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.
authors.affiliation: Department of Statistics, Carnegie Mellon University, 5000 Forbes Avenue, Pittsburgh, PA 15213, U.S.A. joel@stat.cmu.edu
authors.forename: Joel B
authors.initials: JB
authors.lastname: Greenhouse
authors.forename: Eloise E
authors.initials: EE
authors.lastname: Kaizar
authors.forename: Kelly
authors.initials: K
authors.lastname: Kelleher
authors.forename: Howard
authors.initials: H
authors.lastname: Seltman
authors.forename: William
authors.initials: W
authors.lastname: Gardner
mesh_terms: D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D010372:Pediatrics; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D013405:Suicide / Q000523:psychology*
chemical_list: D000928:Antidepressive Agents