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Key Statistical Concepts in Clinical Trials for Pharma

Part of the SpringerBriefs in Pharmaceutical Science & Drug Development Book Series

DOI: 10.1007/978-1-4614-1662-3

ISBN: 978-1-4614-1661-6

Publisher: Springer New York - Springer Journals

Oct 13, 2011

LitStream

Chapter 1Setting the Scene

Turner, J. Rick

Pages: 1 –10

[The ultimate purpose of the results from a clinical trial is not to tell us precisely what happened in that trial, but, in combination with results from other trials in the drug’s clinical development program, to gain insight into likely drug responses in patients who would be prescribed the...
LitStream

Chapter 2Analyzing Safety Data

Turner, J. Rick

Pages: 11 –21

[The safety of a drug is assessed at all stages of its life cycle, from drug discovery through nonclinical development, preapproval clinical development, and all the time it is subsequently on the market. The focus of this chapter is safety assessment during later-stage clinical trials. When a...
LitStream

Chapter 3Assessing Efficacy Data

Turner, J. Rick

Pages: 23 –32

[A drug must demonstrate efficacy to be given marketing approval. That is, it must provide therapeutic benefit to patients with the disease or condition of clinical concern. Efficacy is assessed in two ways: there must be compelling evidence of both statistically significant efficacy and...
LitStream

Chapter 4Confidence Intervals: Additional Commentary

Turner, J. Rick

Pages: 33 –40

[Focus in this chapter falls on two-sided confidence intervals. A two-sided confidence interval constitutes a range of values that are defined by the lower limit and the upper limit of the interval placed around the treatment effect calculated from the trial, which is now referred to as the...
LitStream

Chapter 5Meta-Methodology

Turner, J. Rick

Pages: 41 –49

[Meta-methodology facilitates the quantitative evaluation of the evidence provided by two or more individual clinical trials that have addressed the same research question. It commonly involves not only the statistical combination of summary statistics from various trials (study-level data), but...
LitStream

Chapter 6Benefit–Risk Estimation

Turner, J. Rick

Pages: 51 –58

[Benefit–risk estimation is a key facet of decision-making at both the regulatory (public health) level and the level of individual patient pharmacotherapy. It requires consideration of both benefit and risk. For a drug to receive regulatory approval, the regulatory agency must find a drug to...

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