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Therapy

Improving clinical trial design in psoriasis: Perspectives from the global dermatology community

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Pages 187-193 | Received 29 Mar 2010, Accepted 12 Apr 2010, Published online: 01 Oct 2010

References

  • Menter A, Griffiths CEM. Current and future management of psoriasis. Lancet. 2007;370:272–284.
  • Naldi L, Raho G. Emerging drugs for psoriasis. Expert Opin Emerg Drugs. 2009;14:145–163.
  • Naldi L, Svensson A, Zenoni D, Diepgen T, Elsner P, Grob JJ, . Comparators, study duration, outcome measures and sponsorship in therapeutic trials of psoriasis: Update of the EDEN Psoriasis Survey 2001–2006. Br J Dermatol. Epub 2009 Sept 24.
  • US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry – E 10 Choice of control group and related issues in clinical trials. Rockville, MD: Office of Training and Communication, Division of Drug Information, Center for Drug Evaluation and Research; May 2001. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125802.htm.
  • Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. London: European Medicines Agency; November 2004. Available from: http://www.ema.europa.eu/pdfs/human/ewp/245402en.pdf.
  • Wittowski K, Leonardi C, Gottlieb A, Menter A, Krueger G, Tebbey P, . Empirical evidence for the clinical symptoms of skin, nails, and joints manifesting independently in patients with concomitant psoriasis and psoriatic arthritis. 2010 (submitted for publication: Arthritis & Rheumatism).

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