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clinical study design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings.〔Miquel Porta (2014) "(A dictionary of epidemiology )", 6th edn, New York: Oxford University Press. ISBN 9780199976737.〕 The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. FDA).
Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics.
==Outline of types of designs for clinical studies==
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