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Books > Medicine > General issues > Medical equipment & techniques > Medical research
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Fundamental Concepts for New Clinical Trialists (Paperback)
Loot Price: R1,644
Discovery Miles 16 440
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Fundamental Concepts for New Clinical Trialists (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 working days
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Fundamental Concepts for New Clinical Trialists describes the core
scientific concepts of designing, data monitoring, analyzing, and
reporting clinical trials as well as the practical aspects of
trials not typically discussed in statistical methodology
textbooks. The first section of the book provides background
information about clinical trials. It defines and compares clinical
trials to other types of research studies and discusses clinical
trial phases, registration, the protocol document, ethical issues,
product development, and regulatory processes. It also includes a
special chapter outlining the valuable attributes that
statisticians can develop to maximize their contributions to a
clinical trial. The second section examines scientific issues faced
in each progressive step of a clinical trial. It covers issues in
trial design, such as randomization, blinding, control-group
selection, endpoint selection, superiority versus noninferiority,
and parallel group versus crossover designs; data monitoring;
analyses of efficacy, safety, and benefit-risk; and the
reporting/publication of clinical trial results. As clinical trials
remain the gold standard research studies for evaluating the
effects of a medical intervention, newcomers to the field must have
a fundamental understanding of the concepts to tackle real-world
issues in all stages of trials. Drawing on their experiences in
academia and industry, the authors provide a foundation for
understanding the fundamental concepts necessary for working in
clinical trials.
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