A Practical Guide to Human Research and Clinical Trials  book cover
1st Edition

A Practical Guide to Human Research and Clinical Trials

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ISBN 9781466591172
Published January 29, 2013 by CRC Press
350 Pages

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Book Description

Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.

Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

Table of Contents

Clinical Research – A Clinical Investigator’s Perspective
Scientific and Practical Aspects
Financial Considerations

Medical Device Development, Process and Regulation
Categories of Medical Devices
Evaluation of Medical Devices
Regulatory Process

Pre-Clinical Drug Development
Overview of Drug Discovery and Role of basic Sciences
New Approaches in Drug Discovery
Pharmacological Screening

Phases of Clinical Trials
Phase I
Phase II Studies
Phase III Trials
Phase IV Trials

Phase 0 - Microdosing Studies
Micro-dosing and Exploratory-IND Studies
Characteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies
Goals of Microdosing Studies
Technical Advances
Regulatory Issues
Patient’s Perspective
Informed Consent Issues
Single-dose Toxicity Study in Support of Micro-dosing Studies
Advantages of Micro-dosing
Limitations of Micro-dosing

Clinical Research Planning
Introduction to Clinical Trials
Types of Clinical Trials
The Planning Steps

Clinical Research Design
Elements of Trial Design
Types of Clinical Trial Design

Clinical Research Protocol
Title Page
Signature Page
Contents Page
List of Abbreviations and Definitions
Trial Objectives and Purpose
Study Design
Subject Selection
Subject Recruitment
Trial Interventions
Statistical Considerations
Compliance and Withdrawal
Interim Analysis and Data Monitoring
Ethical Considerations
Financing and Insurance
Reporting and Publication

Designing Case Report Forms
Uses of CRF
Well-Designed CRF
CRF Design Layout
CRF Field Designs
CRF Verification Before Use
Elements of Trial Design
Electronic Data Entry Forms
Points to Remember

Process of Randomization in Clinical Trials
Advantages of Randomization
Types of Randomization
Techniques of Randomisation
Implementation of Randomization Procedure

Investigational Medicinal Products
Manufacturing, Packaging, Labeling, and Coding IMPs
Supply and Handling IMPs
Receipt of IMP, Inventory, Storage and Accountability
Randomization Code
Principles Applicable to Comparator Product
Blinding Operations
Recall, Return, Shipment and Destruction of IMP

Multi-center Clinical Trials
Advantages and Disadvantages
A Common Protocol
A Coordinating Centre
Comparability of Participating institutions
Committees in a Multi-center Trial
Statistical Issues
Analysis of Results
Multinational Clinical Trials

Good Clinical Research Practice
Definition of GCP
Overview of the Clinical Research Process
Principles of GCP

Role and Responsibilities of Sponsor
Contract Research Organization (CRO)
The Sponsor and the investigational Products
Sponsor and Record Access
Safety Information

Role and Responsibilities of Principal Investigator
Competencies and Responsibilities of the Principal Investigator
Qualifications and Availability
Adequate Resources
Informed Consent
Investigational Products
Compliance with Protocol
Monitoring and Auditing
Source Data and Other Documentation
Safety Issues and Reporting of Serious Adverse Events
Premature Termination - Breaking the Treatment Code
Progress Reports, Trial Outcome and Final Study Reports

Ethical Consideration in Clinical Research – Special Reference to Developing Countries
Individuals Involved With Ethical Issues
Ethical Issues Related to Protocol Development and Study Design
Issues on Informed Consent
Ethical Issues During Conduct of a Clinical Research
Access to Post Trial Benefits
Need for Developed Countries to Assist Developing
Countries in Capacity Building

Informed Consent in Clinical Research
Historical Background
Elements of Informed Consent
Language Used in Consent Forms
Informed Consent Waiver
Revising an Informed Consent
Reconsenting Process
Consent Obtained from Special Groups of Patients

Monitoring in Clinical Trials
Types of Monitoring in Clinical Trials
Key Participant in Monitoring of Clinical Trial

Quality Assurance in Clinical Research
Monitoring-Details Presented in Chapter on Monitoring
Data Management Metrics

Pharmacovigilance and Drug Safety
Terms Commonly Used in Drug Safety
The Specific Aims of Pharmacovigilance
ADR Classification and Evolution
Causality Assessment Scales
Important of Post Marketing Surveillance and ADR Reporting
Characteristics of a Good Adverse Drug Reaction Report
Periodic Safety Update Report (PSUR)
MedDRA or Medical Dictionary for Regulatory Activities
Pharmacovigilance in India

Data and Safety Monitoring Board and Monitoring Plan
Definition and Purpose
Data Monitoring Committee
Data Safety Monitoring Plan

Standard Operating Procedures
Standard Operating Procedures
SOP Template
Master Formulation Record

Archiving Clinical Research Documents
Stake Holders
What Documents Must Be Archived
How long Should the Documents be Archived
When to Archive Trail Master File (TMF)
The Archive Building

Evidence Based Medicine
Introduction and Overview
Types of EBM
Categories of Evidence
Categories of Recommendations
Statistical Measures
Quality of Clinical Trial Publications
Limitations of Available Evidence
Criticism of Evidence-Based Medicine

Clinical Research Data Management
Data Management
Final Study Report
Retension and Securing of Records
Archiving by the Principle Investigator
Archiving by the Sponsor

Clinical Biostatistics
(a) Biostatistics for Clinical Researcher
26(a).1 Introduction
26(a).2 Descriptive Statistics
26(a).3 Null Hypothesis and Alternative Hypothesis
26(a).4 Classifications of Data
26(a).5 Test of Hypothesis with the Correct Statistical Tests
26(a).6 Summary
(b) Terminology Used in Biostatistics
26(b).1 Introduction to Biostatistics
26(b).2 Terminology used in Biostatistics
26(b).3 Sampling Unit


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Naidu\, M. U. R.; Rani\, P. Usha