title: Comparison of academic and nonacademic sites in multi-center clinical trials.
abstract: The selection of appropriate subjects is a critical element of successful clinical trials. Failure to properly identify, select, and retain subjects in clinical trials of antidepressant medications may affect the ability to show separation from placebo. Little is known about which type of site, academic or nonacademic, is superior in selecting and retaining appropriate subjects. In the present investigation, the authors conducted a retrospective analysis comparing the performance of academic and nonacademic sites in selecting and retaining appropriate subjects in a recently completed multi-site clinical study of aripiprazole augmentation. The authors used a set of operationalized criteria called the SAFER to identify appropriate study subjects. No significant differences were found in rates of SAFER interview passing, study completion, and clinical outcomes between academic and nonacademic sites. Our findings suggest that academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.
authors.affiliation: Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. cdording@partners.org
authors.forename: Christina M
authors.initials: CM
authors.lastname: Dording
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Dalton
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pencina
authors.forename: Maurizio
authors.initials: M
authors.lastname: Fava
authors.forename: David
authors.initials: D
authors.lastname: Mischoulon
mesh_terms: D000046:Academic Medical Centers; D000047:Academies and Institutes; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D001900:Boston; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D061218:Depressive Disorder, Treatment-Resistant / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006769:Hospitals, General; D006801:Humans; D007406:Interview, Psychological; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010352:Patient Dropouts / Q000523:psychology; D018579:Patient Selection; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole