A Practical Guide to Human Research and Clinical Trials: 1st Edition (Hardback) book cover

A Practical Guide to Human Research and Clinical Trials

1st Edition

By M. U. R. Naidu, P. Usha Rani

CRC Press

350 pages

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Hardback: 9781466591172
pub: 2013-01-29
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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


Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
MEDICAL / Pharmacy
SCIENCE / Chemistry / General