Hoogedoorn L, Peppelman M, Blokx WA, van Erp PE, Gerritsen MJ Prospective differentiation of clinically difficult to distinguish nodular basal cell carcinomas and intradermal nevi by non-invasive Reflectance Confocal Microscopy: a case series study. J Eur Acad Dermatol Venereol. 2015 Feb;29(2):330-6. doi: 10.1111/jdv.12548. Epub 2014 May 20.
Peppelman M, Wolberink EA, Koopman RJ, van Erp PE, Gerritsen MJ In vivo Reflectance Confocal Microscopy: A Useful Tool to Select the Location of a Punch Biopsy in a Large, Clinically Indistinctive Lesion. Case Rep Dermatol. 2013 Apr 25;5(1):129-32. doi: 10.1159/000351258. Print 2013 Jan.
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In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
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.