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137

Research • Statistic & Theory

DesigningClinicalResearch, FourthEdition

StephenB.Hulley,MD,MPH

978-1-60831-804-9 • July2013 • Softbound • 7” x10”pp •59Table

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

epidemiologicconcepts ina reader-friendlyway, and suggestscommon

sense approaches to the challenging judgments involved in designing,

funding, and implementing.

Features

NEW!

Approaches to sample sizeestimation, keeping it simple

while coveringmoredesignoptions.

• Examples and ideasonwhat’s new in clinical research.

• Exercises that highlightmajor clinical research issues.

• Treatmentof clinical trial designand implementation.

• Expandedandupdated content inevery chapter,withnewmaterial

on: non-inferiority trials for comparativeeffectiveness research

incidence-density case-control studies confoundingandeffect

modification; diagnostic test studies to informprediction rules;

ethical aspectsofwholegenome sequencing; automateddata

management approaches; newNIHgrant-writing requirements.

• Color format, andElectronic access, poweredby Inkling

as a

free companion to the text; viewable throughyour browseror

as adownload to tabletor smartphone ; the complete textwith

optimizednavigation; note-sharing, highlightingandbookmarking

capability; cross-linkingof references and content; rapid search

options linked to thenewglossary.

Table of Contents

Section I:

Basic Ingredients

Ch. 1: Getting Started:TheAnatomy and

Physiology of Clinical Research

Ch. 2: Conceiving theResearchQuestion

andDeveloping the Study Plan

Ch. 3: Choosing the Study Subjects:

Specification, Sampling, andRecruitment

Ch. 4: Planning theMeasurements: Precision,

Accuracy andValidity

Ch. 5: GettingReady toEstimate Sample

Size:Hypotheses andUnderlying Principles

Ch. 6: Estimating Sample Size andPower:

Applications andExamples

Section II:

StudyDesigns

Ch. 7:DesigningCross-Sectional andCohort

Studies

Ch. 8:DesigningCase-Control Studies

Ch. 9: EnhancingCausal Inference in

Observational Studies

Ch. 10:Designing aRandomizedBlinded

Trial

Ch. 11: AlternativeTrialDesigns and

Implementation Issues

Ch. 12:Designing Studies ofMedicalTests

Ch. 13: ResearchUsingExistingData

Section III:

Implementation

Ch. 14: AddressingEthical Issues

Ch. 15:DesigningQuestionnaires, Interviews

andOnline Surveys

Ch. 16;DataManagement

Ch. 17: Implementing the Study andQuality

Control

Ch. 18: Community and International

Studies

Ch. 19:Writing andFunding aResearch

Proposal