Abstract
Clinical trials are a key component in the practice of evidence-based medicine. Much thought should be put into the design of a trial and only then should a protocol be developed to ensure that the targeted outcome is successfully achieved. The first duty when considering the methodology to be used in a clinical trial is to ensure the safety of the participants (patients and healthy volunteers). Ethical principles and practices should guide the physicians running the trial, which should be designed and conducted in such a way that the reliability of the data is of the highest possible standard. An experienced statistician should be consulted before the trial commences. Suitable endpoints, methods of comparison, and statistical analyses must be carefully selected to achieve the intended goals of the research. Although running a well-designed clinical trial may appear a relatively straightforward task, the underlying protocols can be flawed unless founded on meticulous methodology. The purpose of this chapter is to provide a brief guide to some factors that need to be considered when designing a clinical trial, with particular emphasis on dermatology.
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Emanuele, E. (2015). Statistics. In: Nasir, A. (eds) Clinical Dermatology Trials 101. Springer, Cham. https://doi.org/10.1007/978-3-319-09027-6_10
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DOI: https://doi.org/10.1007/978-3-319-09027-6_10
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