title: Generalizing from clinical trials.
abstract: Although randomized controlled clinical trials have become the "gold standard" for evaluating new treatments, only a small subset of the population considered for treatment participate in randomized clinical trials. To what extent is it reasonable to generalize beyond the boundaries of a specific clinical trial? This paper argues that several pieces of information are necessary to determine the extent of extrapolation or generalization warranted in a specific clinical trial. The necessary items of information are derived from basic science laboratory studies; animal studies; genetic studies (where applicable); observational, clinical, and epidemiological studies; and other randomized clinical trials in similar settings or with similar treatments. An example from the field of cholesterol reduction is presented.
authors.affiliation: Department of Biostatistics, University of North Carolina, School of Public Health, Chapel Hill 27599-7400.
authors.forename: C E
authors.initials: CE
authors.lastname: Davis
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D002784:Cholesterol / Q000097:blood*; D003327:Coronary Disease / Q000097:blood / Q000517:prevention & control*; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012307:Risk Factors
chemical_list: D002784:Cholesterol