Journal
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Volume 32, Issue 1, Pages 65-68Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JCP.0b013e31823f3b47
Keywords
academic; nonacademic; depression; clinical trial; subject selection
Categories
Funding
- Bristol-Myers Squibb
- Abbott Laboratories
- Alkermes, Inc
- Aspect Medical Systems
- AstraZeneca
- Bristol-Myers Squibb Company
- Cephalon
- Eli Lilly and Company
- Forest Pharmaceuticals, Inc
- GlaxoSmithKline
- Johnson & Johnson Pharmaceuticals
- Lichtwer Pharma GmbH
- Lorex Pharmaceuticals
- Novartis
- Organon, Inc
- Pamlab, LLC
- Pfizer, Inc
- Pharmavite
- Roche
- Sanofi-Aventis
- Solvay Pharmaceuticals, Inc
- Synthelabo
- Wyeth-Ayerst Laboratories
- BioResearch
- BrainCells, Inc
- Cephalon, Inc
- Clinical Trials Solutions, LLC
- Clintara, LLC
- Covidien
- EnVivo Pharmaceuticals, Inc
- Ganeden Biotech, Inc
- Icon Clinical Research
- Johnson & Johnson Pharmaceutical Research Development
- NARSAD
- NCCAM
- NIDA
- NIMH
- Novartis AG
- Organon Pharmaceuticals
- Pharmavite LLC
- RCT Logic, LLC
- Sanofi-Aventis US LLC
- Shire
- Nordic Naturals
- Ganeden
- Independent Medical Education (IME) grants
Ask authors/readers for more resources
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.
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