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Table of Contents
Intro
Preface
Acknowledgments
Contents
About the Authors
List of Figures
List of Tables
1: Designs of Clinical Research and Its Practical Approach
1.1 Introduction
1.1.1 Identification of Research Problem
1.1.2 Literature Survey
1.1.3 Formulating the Research Question
1.1.4 Research Proposal Writing
1.1.5 Institutional Review Board (IRB)
1.1.6 Data Collection and Compilation
1.1.7 Dissemination
1.2 Practical Implication of Study Design in Clinical Research
1.2.1 Objectives of the Book
1.3 Statistical Historical Perspectives of Clinical Trail
1.4 Global Milestone
1.4.1 Indian Milestone
1.5 Clinical Research
1.5.1 Intervention
1.5.2 Nonintervention
1.6 Types of Clinical Research
1.6.1 Patient-Oriented Research
1.6.2 Epidemiological and Behavioral Studies
1.6.3 Outcome and Health-Related Services Research
1.7 Risk in Clinical Research
1.8 Clinical Trial
1.8.1 Treatment Trial
1.8.2 Prevention Trial
1.8.3 Quality of Life Trial
1.8.4 Diagnostic Trial
1.9 Glossary
1.10 Brief Concept of Study Design
1.11 Experimental Study
1.11.1 Randomized Controlled Trail (RCT)
1.11.2 Non-randomized Controlled Trail (RCT)
1.12 Randomization Study
1.12.1 Salient Properties of Randomization
1.12.2 Elimination of Selection Effects
1.12.3 Preclude for Effective Statistical Inference
1.12.4 Subject Assignment-Randomly Assigned Subject to Treatment Groups
1.13 Non-randomization
1.13.1 Cohort Study
1.13.1.1 Elements of Cohort Study Design
1.13.2 Selection of Study Subjects
1.13.3 Carrying Out Research on Special Populations
1.13.4 Justice
1.13.5 Obtaining Data Sets on Exposure
1.13.6 Selection of Comparison
1.13.7 Follow-Up Record
1.13.8 Compilation and Inference
1.13.9 Strength of Cohort Study
1.13.10 Weakness of Cohort Study Design
1.14 Cross-Sectional Study
1.15 Longitudinal Study
1.16 Prospective Study
1.17 Retrospective Study: Case-Control
1.18 Case-Control Study
1.19 Open and Double-Blind Trials
1.20 Open Trial
1.21 Double-Blind Trials
1.22 Some Special Problems of Double-Blind Trials
1.23 Color Matching
1.23.1 Dosage Matching
1.23.2 Duration Matching
1.23.3 Time of Administration and Matching
1.23.4 Data Collection and Quality Assurance
1.23.5 Baseline Visit
1.23.6 Follow-Up Visit
1.23.7 Follow-Up Visits Key Points
1.23.8 Visit Time Limits
1.23.9 Quality Assurance
1.23.10 Visual Check
1.23.11 Data Entry and Verification
1.23.12 Data Edit
1.23.13 Replication
1.23.14 Quality Control of Lab Data
1.23.15 Site Visits
1.23.15.1 Patient Follow-Up
1.23.15.2 Patient Close-Out
1.23.15.3 Patient Post-trial Follow-Up
1.24 Management of Investigator and Patient Interest
1.24.1 During Follow-Up
1.24.2 Investigator Interest
Preface
Acknowledgments
Contents
About the Authors
List of Figures
List of Tables
1: Designs of Clinical Research and Its Practical Approach
1.1 Introduction
1.1.1 Identification of Research Problem
1.1.2 Literature Survey
1.1.3 Formulating the Research Question
1.1.4 Research Proposal Writing
1.1.5 Institutional Review Board (IRB)
1.1.6 Data Collection and Compilation
1.1.7 Dissemination
1.2 Practical Implication of Study Design in Clinical Research
1.2.1 Objectives of the Book
1.3 Statistical Historical Perspectives of Clinical Trail
1.4 Global Milestone
1.4.1 Indian Milestone
1.5 Clinical Research
1.5.1 Intervention
1.5.2 Nonintervention
1.6 Types of Clinical Research
1.6.1 Patient-Oriented Research
1.6.2 Epidemiological and Behavioral Studies
1.6.3 Outcome and Health-Related Services Research
1.7 Risk in Clinical Research
1.8 Clinical Trial
1.8.1 Treatment Trial
1.8.2 Prevention Trial
1.8.3 Quality of Life Trial
1.8.4 Diagnostic Trial
1.9 Glossary
1.10 Brief Concept of Study Design
1.11 Experimental Study
1.11.1 Randomized Controlled Trail (RCT)
1.11.2 Non-randomized Controlled Trail (RCT)
1.12 Randomization Study
1.12.1 Salient Properties of Randomization
1.12.2 Elimination of Selection Effects
1.12.3 Preclude for Effective Statistical Inference
1.12.4 Subject Assignment-Randomly Assigned Subject to Treatment Groups
1.13 Non-randomization
1.13.1 Cohort Study
1.13.1.1 Elements of Cohort Study Design
1.13.2 Selection of Study Subjects
1.13.3 Carrying Out Research on Special Populations
1.13.4 Justice
1.13.5 Obtaining Data Sets on Exposure
1.13.6 Selection of Comparison
1.13.7 Follow-Up Record
1.13.8 Compilation and Inference
1.13.9 Strength of Cohort Study
1.13.10 Weakness of Cohort Study Design
1.14 Cross-Sectional Study
1.15 Longitudinal Study
1.16 Prospective Study
1.17 Retrospective Study: Case-Control
1.18 Case-Control Study
1.19 Open and Double-Blind Trials
1.20 Open Trial
1.21 Double-Blind Trials
1.22 Some Special Problems of Double-Blind Trials
1.23 Color Matching
1.23.1 Dosage Matching
1.23.2 Duration Matching
1.23.3 Time of Administration and Matching
1.23.4 Data Collection and Quality Assurance
1.23.5 Baseline Visit
1.23.6 Follow-Up Visit
1.23.7 Follow-Up Visits Key Points
1.23.8 Visit Time Limits
1.23.9 Quality Assurance
1.23.10 Visual Check
1.23.11 Data Entry and Verification
1.23.12 Data Edit
1.23.13 Replication
1.23.14 Quality Control of Lab Data
1.23.15 Site Visits
1.23.15.1 Patient Follow-Up
1.23.15.2 Patient Close-Out
1.23.15.3 Patient Post-trial Follow-Up
1.24 Management of Investigator and Patient Interest
1.24.1 During Follow-Up
1.24.2 Investigator Interest