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Fundamentals of Clinical Research

Part of the Statistics for Biology and Health Book Series

DOI: 10.1007/978-88-470-0492-4

ISBN: 978-88-470-0491-7

Publisher: Springer Milan - Springer Journals

Jan 1, 2007

1 - 10 of 12 Chapters

Available

Viability of Biological Phenomena and Measurement Errors

Pages: 1 –13

[The variability of biological phenomena, as we perceive them, can be divided into three main components: phenotypic, temporal and measurement-related. Measurement-related variability includes every source of variation that occurs as a consequence of measurements and interpretation of results.]
Available

Distinctive Aspects of a Biomedical Study Observational and Experimental Studies

Pages: 14 –27

[The aims of this chapter are, firstly, to introduce aspects which are common to all biomedical studies, and, secondly, to discuss the features that distinguish observational from experimental studies, the two fundamental categories of biomedical studies.]
Available

Observational Studies

Pages: 28 –57

[In this chapter we give a brief overview of observational studies, also referred to as epidemiological studies (as mentioned above, we use these terms interchangeably). The rest of the book is dedicated to clinical trials, which belong to the category of experimental studies (see chapter 2). We...
Available

Defining the Treatment Effect

Pages: 58 –89

[In this book we will use the term “signal” to define the summary variable which, at a group level and in comparative terms, is used to formulate the hypothesis to be tested, in order to evaluate the effect of the experimental treatment under study. It should be noted that in clinical research...
Available

Probability, Inference and Decision Making

Pages: 90 –156

[In writing this chapter we have three special debts of gratitude to acknowledge. One is to Professor Theodore Colton for the frequentist approach, outlined with simplicity and rigor in his textbook on clinical trials [26]. The second is to Professor Ludovico Piccinato, of the University of Rome,...
Available

The Choice of the Sample

Pages: 157 –171

[The sample is the group of subjects on which the study is performed. Two aspects, one qualitative and the other quantitative, must be considered when choosing the sample.]
Available

The Choice of Treatments

Pages: 172 –182

[aIn line with the terminology introduced in section 2.4, in this chapter we shall use the term “experimental treatment” when referring to the main object of a clinical trial (often a novel treatment), and the term “study treatments” when referring to both experimental and control treatments.]
Available

Experimental Design: Fallacy of “Before-After” Comparisons in Uncontrolled Studies

Pages: 183 –199

[The design of an experiment is defined as the method by which subjects (experimental units) are assigned to treatments. The chosen method of assignment in turn determines the way in which the data collected in the study are analyzed.]
Available

Experimental Design: the Randomized Blinded Study as an Instrument to Reduce Bias

Pages: 200 –227

[From the previous chapter it should be clear that in most cases the before-after comparison in a single group of patients is an inadequate experimental design, as it fails to achieve comparisons free from bias. “Before” is not a good control for “after”, since the effects of many factors are...
Available

Experimental Designs

Pages: 228 –276

[A preliminary remark for those readers who master some statistics: this chapter is limited to the linear model, which anyway is a sufficiently broad platform to cover most of the clinical applications.]

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