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|a Nadkarni, Prakash,
|e author.
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|a Clinical research computing :
|b a practitioner's handbook /
|c Prakash Nadkarni.
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|a London :
|b Academic Press,
|c 2016.
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| 300 |
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|a computer
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|a Includes bibliographical references and index.
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|a Vendor-supplied metadata.
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|a Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities.
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| 505 |
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|a Cover; Title Page; Copyright Page; Content; Foreword; Motivation; Choice of terms; The target audience; Scope of the book; Acknowledgments; Bibliography; Chapter 1 -- An Introduction to Clinical Research Concepts; 1.1 -- Introduction; 1.2 -- The level of evidence hierarchy; 1.2.1 -- Limitations of the evidence hierarchy; 1.3 -- A bird's-eye view of statistics in clinical research; 1.3.1 -- Teaching yourself statistics: why; 1.3.2 -- Teaching yourself statistics: how; 1.3.2.1 -- Cost considerations; 1.3.3 -- Hypothesis testing and statistical inference in clinical research.
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| 505 |
8 |
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|a 1.3.4 -- Type I errors: the choice of the p value1.3.4.1 -- Multiple hypothesis correction; 1.3.4.2 -- Data dredging; 1.3.5 -- Type II errors: power analysis and sample size; 1.3.6 -- Interpreting negative results studies with adequate power and sample size; 1.4 -- Clinical studies of investigational therapies; 1.4.1 -- Phase I: early safety testing and dose determination; 1.4.2 -- Phase II: the open therapeutic trial; 1.4.3 -- Phase III: the comparative/controlled clinical trial; 1.4.4 -- Phase IV: postmarketing surveillance; 1.5 -- Clinical studies of established therapies.
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|a 1.6 -- Experimental design of comparative-effectiveness studies1.6.1 -- Factors influencing therapeutic response; 1.6.2 -- Separate patient groups: stratified randomization; 1.6.3 -- Chronic conditions: crossover design; 1.6.4 -- Placebo effects: double-blind designs; 1.6.5 -- Pragmatic clinical trials; 1.7 -- Evaluation of medical software; 1.8 -- Further reading; 1.8.1 -- Biomedical basics; 1.8.2 -- Texts on clinical research; Bibliography; Chapter 2 -- Supporting Clinical Research Computing: Technological and Nontechnological Considerations; 2.1 -- Technological aspects: software development.
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| 505 |
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|a 2.1.1 -- Software-construction tasks: the development process2.1.1.1 -- Rapid functional prototyping; 2.1.1.2 -- Early testing and continuous integration; 2.1.1.3 -- Evolutionary delivery; 2.1.1.4 -- "Agile" development; 2.1.1.5 -- Use the simplest technology that meets requirements; 2.2 -- Nontechnical factors: overview; 2.3 -- Attitude: service versus research; 2.3.1 -- Balancing act; 2.4 -- Technical skills; 2.4.1 -- Minimal technical skillset; 2.5 -- General skills and breadth of knowledge; 2.6 -- Communication skills; 2.7 -- Managing people and projects; 2.7.1 -- Multifunctional teams.
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|a 2.7.2 -- Software project management2.7.3 -- Effective and ineffective teams: interpersonal factors; 2.7.4 -- Exploitative practices: a selfish reason not to employ them; 2.8 -- Personality traits; 2.8.1 -- Personality profiling: a word of warning; 2.9 -- Negotiation skills; 2.10 -- Choosing your collaborators; 2.10.1 -- Supporting junior faculty; 2.10.2 -- Scoping the project: change control; 2.11 -- Topics in clinical research support; 2.11.1 -- Special aspects of supporting investigational drug studies; Bibliography; Chapter 3 -- Core Informatics Technologies: Data Storage.
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| 505 |
8 |
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|a 3.1 -- Types of data elements: databases 101.
|
| 650 |
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0 |
|a Medicine
|x Data processing.
|0 http://id.loc.gov/authorities/subjects/sh85083074
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2 |
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|i Print version:
|a Nadkarni, Prakash.
|t Clinical research computing.
|d London : Academic Press, 2016
|z 0128031301
|z 9780128031308
|w (OCoLC)938383501
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