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

Journal of Dermatological Treatment

Volumn 22, Issue 4, 2011, Pages 187-193

  Kerkhof, Peter Van De ^a   Barker, Jonathan ^b   Griffiths, Christopher E M ^c   Menter, Alan ^d   Leonardi, Craig ^e   Young, Melodie ^f   Kemeny, Lajos ^g   Pincelli, Carlo ^h   Bachelez, Hervé ⁱ   Katsambas, Andreas ^j   Ståhle, Mona ^k   Horn, Elizabeth J ^l   Sterry, Wolfram ^m  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ST THOMAS HOSPITAL   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d BAYLOR RESEARCH INSTITUTE   (United States)

^e SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f Modern Dermatology Aesthetics Center   (United States)

^g UNIVERSITY OF SZEGED   (Hungary)

^h UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

ⁱ SAINT LOUIS HOSPITAL   (France)

^j UNIVERSITY OF ATHENS   (Greece)

^k KAROLINSKA INSTITUTE   (Sweden)

^l International Psoriasis Council   (United States)

^m CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

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Author keywords

Clinical trials; Control groups; Investigational drugs; Psoriasis

Indexed keywords

ADALIMUMAB; ALEFACEPT; BETAMETHASONE DIPROPIONATE PLUS CALCIPOTRIOL; CALCIPOTRIOL; CLOBETASOL PROPIONATE; COLECALCIFEROL DERIVATIVE; CORTICOSTEROID; CYCLOSPORIN; DITHRANOL; ETANERCEPT; ETRETIN; FUMARIC ACID; HYDROCORTISONE; INFLIXIMAB; METHOTREXATE; TRIAMCINOLONE ACETONIDE; TUMOR NECROSIS FACTOR INHIBITOR; USTEKINUMAB; VITAMIN D DERIVATIVE;

CHRONIC PLAQUE PSORIASIS; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); COMORBIDITY; DISEASE SEVERITY; DRUG TREATMENT FAILURE; ERYTHRODERMIC PSORIASIS; FACIAL PSORIASIS; FLEXURAL PSORIASIS; GENERALIZED PUSTULAR PSORIASIS; HEALTH SURVEY; HUMAN; LONG TERM CARE; PALMAR PLANTAR PSORIASIS; PALMAR PLANTAR PUSTULOSIS; PHOTOTHERAPY; PRIORITY JOURNAL; PSORIASIS; PSORIASIS GUTTATA; PSORIASIS VULGARIS; QUALITY OF LIFE; QUESTIONNAIRE; RELAPSE; REVIEW; SCALP PSORIASIS; TREATMENT FAILURE;

CONTROL GROUPS; HUMANS; PSORIASIS; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 79960454897     PISSN: 09546634     EISSN: 14711753     Source Type: Journal    
DOI: 10.3109/09546634.2010.487888     Document Type: Review

References (6)

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4. 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.
5. 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.
6. Wittowski K, Leonardi C, Gottlieb A, Menter A, Krueger G, Tebbey P, et al. 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).