1st Edition

A Practical Guide to Human Research and Clinical Trials

By M. U. R. Naidu, P. Usha Rani Copyright 2013
    350 Pages
    by CRC Press

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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.

    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



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