Psoriasis — Efficacy of Novel Drug-combinations for Relief of Psoriasis
Citation(s)
Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264. Erratum in: JAMA Dermatol. 2014 Mar;150(3):337. JAMA Dermatol. 2014 Jan;150(1):103.
Choi J, Koo JY Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. Review.
Unaeze J, Nijsten T, Murphy A, Ravichandran C, Stern RS Impact of psoriasis on health-related quality of life decreases over time: an 11-year prospective study. J Invest Dermatol. 2006 Jul;126(7):1480-9. Epub 2006 Mar 30.
Efficacy of Novel Drug-combinations for Relief of Psoriasis (ENDURE)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.