Catalogue


Principles and practice of clinical trial medicine [electronic resource] /
Richard Chin, Bruce Y. Lee.
imprint
Amsterdam ; Boston : Elsevier/Academic Press, c2008.
description
xii, 547 p. : ill. ; 28 cm.
ISBN
0123736951, 9780123736956
format(s)
Book
More Details
added author
imprint
Amsterdam ; Boston : Elsevier/Academic Press, c2008.
isbn
0123736951
9780123736956
restrictions
Licensed for access by U. of T. users.
general note
Includes index.
catalogue key
8036649
A Look Inside
Summaries
Bowker Data Service Summary
Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.
Main Description
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. *Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data. *Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine. *Expert authorship whose experience includes running clinical trials in an academic as well as industry settings. *Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.
Main Description
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. *Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data *Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine *Expert authorship whose experience includes running clinical trials in an academic as well as industry settings *Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
Table of Contents
Overview
Overview of Clinical Research Medicine
Ethical, Legal, and Regulatory Issues
The General Structure of Clinical Trials and Programs
Introduction to Clinical Trial Statistics
Measures and Variables
Study Groups
Periods, Sequences, and Trial Design
Key Components of Clinical Trials and Programs
Endpoints
Economics and Patient Reported Outcomes
Patient Selection and Sampling
Dosing and Intervention
Epidemiology, Decision Analysis, and Simulation
Conduct of the Study
Study Execution
Site Selection and Patient Recruitment
Analysis of Results
Assessing Data Quality and Transforming Data
Analysis of Data
Data Interpretation and Conclusions
Concluding Remarks and Future Directions
Appendices
FDA Internal Compliance Manuals
Medwatch Form
Sample Investigators Brochure
Sample Case Report Form
Sample Investigational New Drug Application Form
Statement of Investigator Form
SAE/SUSAR Initial Report Form
Table of Contents provided by Publisher. All Rights Reserved.

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