a Concise guide to Clinical Trials 1st Edition by Allan Hackshaw ISBN 1405167742 9781405167741

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ISBN 10: 1405167742
ISBN 13: 9781405167741 
Author: Allan Hackshaw
 Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle.

A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations.

This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at:

• Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials

• Health professionals who wish to conduct their own trials, or participate in other people’s studies
• People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

a Concise guide to Clinical Trials 1st Edition Table of contents:

Chapter 1: Introduction to Clinical Trials

• What is a Clinical Trial?
• Types of Clinical Trials
• The Role of Clinical Trials in Medical Research
• Ethical Considerations in Clinical Trials

Chapter 2: Designing a Clinical Trial

• Defining the Research Question
• Choosing the Study Design (Randomized, Observational, etc.)
• Selection of Participants: Inclusion and Exclusion Criteria
• Sample Size Calculation and Power Analysis
• Randomization and Control Groups

Chapter 3: Ethical and Regulatory Aspects

• Ethical Principles in Clinical Trials
• Informed Consent and Participant Rights
• Regulatory Framework: ICH-GCP, FDA, and EMA Guidelines
• Institutional Review Boards (IRBs) and Ethics Committees

Chapter 4: Planning and Implementation

• Developing a Trial Protocol
• Data Management and Record Keeping
• Trial Coordination and Monitoring
• Managing Adverse Events and Safety Reporting

Chapter 5: Statistical Methods in Clinical Trials

• Basic Statistical Concepts and Terminology
• Analyzing Clinical Trial Data
• Types of Outcome Measures: Primary, Secondary, and Surrogate Endpoints
• Statistical Tests and Data Analysis Techniques

Chapter 6: Recruitment and Retention of Participants

• Strategies for Participant Recruitment
• Overcoming Recruitment Barriers
• Maintaining Participant Engagement and Retention
• Handling Dropouts and Missing Data

Chapter 7: Conducting the Trial

• Implementing the Trial Protocol
• Monitoring and Auditing During the Trial
• Data Collection and Quality Control
• Managing Trial Sites and Multicenter Trials

Chapter 8: Data Analysis and Interpretation

• Analyzing Primary and Secondary Outcomes
• Interpreting Results: Statistical Significance vs. Clinical Significance
• Subgroup Analysis and Sensitivity Analysis
• Dealing with Bias and Confounding Factors

Chapter 9: Reporting Clinical Trial Results

• Writing Trial Reports and Research Papers
• Reporting Guidelines: CONSORT and Others
• Presenting Results at Conferences
• Peer Review and Publication Ethics

Chapter 10: Common Challenges in Clinical Trials

• Dealing with Recruitment Challenges
• Addressing Ethical Dilemmas and Conflicts of Interest
• Managing Trial Costs and Funding
• Overcoming Limitations in Trial Design

Chapter 11: The Future of Clinical Trials

• Innovations in Clinical Trial Design
• The Role of Technology and Digital Health in Clinical Trials
• Adaptive Trials and Personalized Medicine
• Globalization and Cross-National Trials

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