Titlebook: Key Statistical Concepts in Clinical Trials for Pharma; J. Rick Turner Book 2012 The Author(s) 2012 Clinical Trials.Pharma.Statistical Con

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Assessing Efficacy Data,n of clinical concern. Efficacy is assessed in two ways: there must be compelling evidence of both statistically significant efficacy and clinically significant efficacy. The former is addressed via formalized hypothesis testing involving the creation of a research question, a research hypothesis, a

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Meta-Methodology,me research question. It commonly involves not only the statistical combination of summary statistics from various trials (study-level data), but also refers to analyses performed on the combination of subject-level data. Reasons for employing this methodology include: providing a more precise estim

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,Benefit–Risk Estimation,rapy. It requires consideration of both benefit and risk. For a drug to receive regulatory approval, the regulatory agency must find a drug to have a favorable benefit–risk profile: The benefit to the population as a whole must outweigh any potential risk to certain individuals, who will be protecte

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J. Rick TurnerDiscusses key statistical concepts.Includes supplementary material:

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SpringerBriefs in Pharmaceutical Science & Drug Developmenthttp://image.papertrans.cn/k/image/542590.jpg

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Key Statistical Concepts in Clinical Trials for Pharma978-1-4614-1662-3Series ISSN 1864-8118 Series E-ISSN 1864-8126

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https://doi.org/10.1007/978-1-4614-1662-3Clinical Trials; Pharma; Statistical Concepts; Statistics

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Book 2012prove a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.