4.1 Article

Comparison of Academic and Nonacademic Sites in Multi-Center Clinical Trials

Journal

JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Volume 32, Issue 1, Pages 65-68

Publisher

LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JCP.0b013e31823f3b47

Keywords

academic; nonacademic; depression; clinical trial; subject selection

Funding

  1. Bristol-Myers Squibb
  2. Abbott Laboratories
  3. Alkermes, Inc
  4. Aspect Medical Systems
  5. AstraZeneca
  6. Bristol-Myers Squibb Company
  7. Cephalon
  8. Eli Lilly and Company
  9. Forest Pharmaceuticals, Inc
  10. GlaxoSmithKline
  11. Johnson & Johnson Pharmaceuticals
  12. Lichtwer Pharma GmbH
  13. Lorex Pharmaceuticals
  14. Novartis
  15. Organon, Inc
  16. Pamlab, LLC
  17. Pfizer, Inc
  18. Pharmavite
  19. Roche
  20. Sanofi-Aventis
  21. Solvay Pharmaceuticals, Inc
  22. Synthelabo
  23. Wyeth-Ayerst Laboratories
  24. BioResearch
  25. BrainCells, Inc
  26. Cephalon, Inc
  27. Clinical Trials Solutions, LLC
  28. Clintara, LLC
  29. Covidien
  30. EnVivo Pharmaceuticals, Inc
  31. Ganeden Biotech, Inc
  32. Icon Clinical Research
  33. Johnson & Johnson Pharmaceutical Research Development
  34. NARSAD
  35. NCCAM
  36. NIDA
  37. NIMH
  38. Novartis AG
  39. Organon Pharmaceuticals
  40. Pharmavite LLC
  41. RCT Logic, LLC
  42. Sanofi-Aventis US LLC
  43. Shire
  44. Nordic Naturals
  45. Ganeden
  46. 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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