Km. Carroll et al., 'Research' versus 'real-world' patients: representativeness of participants in clinical trials of treatments for cocaine dependence, DRUG AL DEP, 54(2), 1999, pp. 171-177
Rigorous clinical trials have been criticized as having limited external va
lidity, and specifically that subjects participating in clinical trials are
not representative of individuals seen in clinical practice. To assess the
representativeness of subjects participating in clinical trials, 243 resea
rch subjects participating in clinical trials of treatments for cocaine dep
endence were compared to a sub-sample of 213 individuals being treated for
cocaine dependence in outpatient clinical settings from a large national da
tabase. The data suggest that research findings are not invariably based on
less challenging patients with mild forms of substance dependence and rela
ted problems; moreover research patients may be similar to, if not more sev
ere than, individuals with cocaine problems seen in regular clinical settin
gs in the community. (C) 1999 Published by Elsevier Science Ireland Ltd. Al
l rights reserved.