Home / Medicine / Designing Clinical Research
9781608318049
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9781608318049
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July 2, 2013
2013-07-2
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9781608318049
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Center; Adjunct Professor, Department of Epidemiology \u0026amp; Biostatistics, University of California, San Francisco\u003c/div\u003e\u003c/dd\u003e\u003c/dl\u003e\u003cdl\u003e\u003cdt\u003eDeborah G Grady MD, MPH\u003c/dt\u003e\u003cdd\u003e\u003cdiv\u003e\u003cp\u003eProfessor of Medicine, Associate Dean for Clinical and Translational Research, University of California, San Francisco\u003c/p\u003e\u003c/div\u003e\u003c/dd\u003e\u003c/dl\u003e\u003cdl\u003e\u003cdt\u003eThomas B Newman MD, MPH\u003c/dt\u003e\u003cdd\u003e\u003cdiv\u003eProfessor of Epidemiology \u0026amp; Biostatistics, and of Pediatrics; Chief, Division of Clinical Epidemiology; Attending Physician, Department of Pediatrics, University of California, San 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Ingredients\u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e1  Getting Started: The Anatomy and Physiology of Clinical Research\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eStephen B. Hulley, Thomas B. Newman, and Steven R. Cummings\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e2  Conceiving the Research Question and Developing the Study Plan\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eSteven R. Cummings, Warren S. Browner, and Stephen B. Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e3  Choosing the Study Subjects: Specification, Sampling, and Recruitment\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eStephen B. Hulley, Thomas B. Newman, and Steven R. Cummings\u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e4  Planning the Measurements: Precision, Accuracy and Validity\u003c/p\u003eStephen B. Hulley, Thomas B. Newman and Steven R. Cummings\u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e5  Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eWarren S. Browner, Thomas B. Newman, and Stephen B. Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e6  Estimating Sample Size and Power: Applications and Examples\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eWarren S. Browner, Thomas B. Newman, and Stephen B. Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027sn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003eSection\u0026emsp;II\u003c/p\u003e\u003cp class=\u0027st\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003eStudy Designs\u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e7  Designing Cross-Sectional and Cohort Studies\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eStephen B. Hulley, Steven R. Cummings, and Thomas B. 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Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027margin: 0cm 0cm 0pt\u0027\u003e11  Alternative Trial Designs and Implementation Issues\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 0pt\u0027\u003eDeborah Grady, Steven R. Cummings, and Stephen B. Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e12  Designing Studies of Medical Tests\u003cBR\u003eThomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B. Hulley\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003e \u003c/p\u003e\u003cp class=\u0027cn\u0027 style=\u0027line-height: normal; margin: 0cm 0cm 0pt\u0027\u003e13  Research Using Existing Data\u003c/p\u003e\u003cp class=\u0027MsoNormal\u0027 style=\u0027margin: 0cm 0cm 10pt\u0027\u003eDeborah Grady, Steven R. 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  • Description

    Publisher’s Note:   Products purchased from 3rd Party sellers are not guaranteed by the Publisher for quality, authenticity, or access to any online entitlements included with the product.

    Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches to the challenging judgments involved in designing, funding, and implementing.

    New to this edition:

    • Expanded and updated content in every chapter, with new material on: • non-inferiority trials for comparative effectiveness research • incidence-density case-control studies • confounding and effect modification • diagnostic test studies to inform prediction rules • ethical aspects of whole genome sequencing • automated data management approaches • new NIH grant-writing requirements
    • Color format, and Electronic access, powered by Inkling™ as a free companion to the text • viewable through your browser or as a download to tablet or smartphone • the complete text with optimized navigation • note-sharing, highlighting and bookmarking capability • cross-linking of references and content • rapid search options linked to the new glossary
  • Specs
    Edition
    4
    ISBN/ISSN
    9781608318049
    Product Format
    PB-Paperback
    Trim Size
    7 x 10
    Pages
    0
    Illustration
    42
    Table
    59
    Publication Date
    July 2, 2013
    Weight
    1.45
  • About The Author(s)
    Stephen B Hulley MD, MPH
    Chairman, Dept. of Epidemiology & Biostatistics, UCSF
    Steven R Cummings MD
    Founding Director, San Francisco Coordinating Center; Senior Scientist, California Pacific Medical Center Research Institute; Professor Emeritus, University of California, San Francisco
    Warren S Browner MD, MPH
    Chief Executive Officer, California Pacific Medical Center; Adjunct Professor, Department of Epidemiology & Biostatistics, University of California, San Francisco
    Deborah G Grady MD, MPH

    Professor of Medicine, Associate Dean for Clinical and Translational Research, University of California, San Francisco

    Thomas B Newman MD, MPH
    Professor of Epidemiology & Biostatistics, and of Pediatrics; Chief, Division of Clinical Epidemiology; Attending Physician, Department of Pediatrics, University of California, San Francisco
  • Features
    4 -color design
    New approaches to sample size estimation, keeping it simple while covering more design options
    Examples and ideas on what's new in clinical research
    Exercises that highlight major clinical research issues
    Treatment of clinical trial design and implementation

    NEW to this edition:
    • Expanded and updated content in every chapter, with new material on: • non-inferiority trials for comparative effectiveness research • incidence-density case-control studies • confounding and effect modification • diagnostic test studies to inform prediction rules • ethical aspects of whole genome sequencing • automated data management approaches • new NIH grant-writing requirements
    • Electronic access, powered by Inkling™ as a free companion to the text • viewable through your browser or as a download to tablet or smartphone • the complete text with optimized navigation • note-sharing, highlighting and bookmarking capability • cross-linking of references and content • rapid search options linked to the new glossary
  • Table of contents

    Section I

    Basic Ingredients

     

    1  Getting Started: The Anatomy and Physiology of Clinical Research

    Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

     

    2  Conceiving the Research Question and Developing the Study Plan

    Steven R. Cummings, Warren S. Browner, and Stephen B. Hulley

     

    3  Choosing the Study Subjects: Specification, Sampling, and Recruitment

    Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

     

     

    4  Planning the Measurements: Precision, Accuracy and Validity

    Stephen B. Hulley, Thomas B. Newman and Steven R. Cummings

     

    5  Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles

    Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

     

    6  Estimating Sample Size and Power: Applications and Examples

    Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

     

    Section II

    Study Designs

     

    7  Designing Cross-Sectional and Cohort Studies

    Stephen B. Hulley, Steven R. Cummings, and Thomas B. Newman

     

    8  Designing Case–Control Studies
    Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B.Hulley

     

     

    9  Enhancing Causal Inference in Observational Studies
    Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley

     

    10  Designing a Randomized Blinded Trial

    Steven R. Cummings, Deborah Grady, and Stephen B. Hulley

     

    11  Alternative Trial Designs and Implementation Issues

    Deborah Grady, Steven R. Cummings, and Stephen B. Hulley

     

    12  Designing Studies of Medical Tests
    Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B. Hulley

     

    13  Research Using Existing Data

    Deborah Grady, Steven R. Cummings and Stephen B. Hulley

     

    Section III

    Implementation

     

    14  Addressing Ethical Issues

    Bernard Lo and Deborah Grady

     

    15  Designing Questionnaires, Interviews and Online Surveys

    Steven R. Cummings, Michael A. Kohn, and Stephen B. Hulley

     

    16   Data Management

    Michael A. Kohn, Thomas B. Newman, and Stephen B. Hulley

     

    17  Implementing the Study and Quality Control

    Deborah Grady and Stephen B. Hulley

     

    18  Community and International Studies

    Norman Hearst and Thomas Novotny

     

    19  Writing and Funding a Research Proposal

    Steven R. Cummings and Stephen B. Hulley

     

    Exercises

    Answers to Exercises

    Glossary
  • Review