Description
Book SynopsisRegulatory 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 ContentsClinical Research – A Clinical Investigator’s Perspective
Introduction
Scientific and Practical Aspects
Financial Considerations
Medical Device Development, Process and Regulation
Introduction
Categories of Medical Devices
Evaluation of Medical Devices
Regulatory Process
Pre-Clinical Drug Development
Introduction
Overview of Drug Discovery and Role of basic Sciences
New Approaches in Drug Discovery
Pharmacological Screening
Phases of Clinical Trials
Introduction
Phase I
Phase II Studies
Phase III Trials
Phase IV Trials
Phase 0 - Microdosing Studies
Introduction
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
Conclusion
Clinical Research Planning
Introduction to Clinical Trials
Types of Clinical Trials
The Planning Steps
Clinical Research Design
Introduction
Elements of Trial Design
Types of Clinical Trial Design
Clinical Research Protocol
Title Page
Signature Page
Contents Page
List of Abbreviations and Definitions
Summary
Background
Trial Objectives and Purpose
Study Design
Subject Selection
Subject Recruitment
Trial Interventions
Randomisations
Blinding
Data
Statistical Considerations
Compliance and Withdrawal
Interim Analysis and Data Monitoring
Ethical Considerations
Financing and Insurance
Reporting and Publication
Designing Case Report Forms
Introduction
Uses of CRF
Well-Designed CRF
CRF Design Layout
CRF Field Designs
CRF Verification Before Use
Elements of Trial Design
Electronic Data Entry Forms
Conclusion
Points to Remember
Process of Randomization in Clinical Trials
Introduction
Advantages of Randomization
Types of Randomization
Techniques of Randomisation
Implementation of Randomization Procedure
Investigational Medicinal Products
Definition
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
Introduction
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
Introduction
Definition of GCP
Overview of the Clinical Research Process
Principles of GCP
Role and Responsibilities of Sponsor
Introduction
Contract Research Organization (CRO)
The Sponsor and the investigational Products
Sponsor and Record Access
Safety Information
Role and Responsibilities of Principal Investigator
Introduction
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
Introduction
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
Introduction
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
Introduction
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
Audit
Inspections
Data Management Metrics
Pharmacovigilance and Drug Safety
Introduction
Terms Commonly Used in Drug Safety
The Specific Aims of Pharmacovigilance
Definitions
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
Introduction
Standard Operating Procedures
SOP Template
Master Formulation Record
Archiving Clinical Research Documents
Introduction
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
History
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
Introduction
Protocol
Randomisation
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
Glossary
