Essentials of Clinical Trials
Dr. Nilesh Panchal
This audiobook is narrated by a digital voice.
Essentials of Clinical Trials is an authoritative guide that offers a comprehensive exploration of the essential elements and advanced concepts in clinical research. This textbook delves into the fundamental principles of trial design, ethical considerations, data collection and management, and statistical methodologies, providing a clear and thorough understanding for students, researchers, and professionals. Additionally, it addresses contemporary topics such as adaptive trial designs, pragmatic trials, patient-reported outcomes, and precision medicine, highlighting the integration of big data and artificial intelligence. By combining practical insights with cutting-edge advancements, this book equips readers with the knowledge and tools needed to navigate the evolving landscape of clinical trials and contribute to the advancement of medical science.
Duration - 3h 18m.
Author - Dr. Nilesh Panchal.
Narrator - Digital Voice Madison G.
Published Date - Monday, 20 January 2025.
Copyright - © 2024 Nileshkumar Panchal ©.
Location:
United States
Networks:
Dr. Nilesh Panchal
Digital Voice Madison G
Clinical Trials Mastery Series
DrMedHealth
English Audiobooks
Findaway Audiobooks
Description:
This audiobook is narrated by a digital voice. Essentials of Clinical Trials is an authoritative guide that offers a comprehensive exploration of the essential elements and advanced concepts in clinical research. This textbook delves into the fundamental principles of trial design, ethical considerations, data collection and management, and statistical methodologies, providing a clear and thorough understanding for students, researchers, and professionals. Additionally, it addresses contemporary topics such as adaptive trial designs, pragmatic trials, patient-reported outcomes, and precision medicine, highlighting the integration of big data and artificial intelligence. By combining practical insights with cutting-edge advancements, this book equips readers with the knowledge and tools needed to navigate the evolving landscape of clinical trials and contribute to the advancement of medical science. Duration - 3h 18m. Author - Dr. Nilesh Panchal. Narrator - Digital Voice Madison G. Published Date - Monday, 20 January 2025. Copyright - © 2024 Nileshkumar Panchal ©.
Language:
English
Chapter 1: Introduction to Clinical Trials
Duration:00:00:05
Importance and History
Duration:00:05:27
Types of Clinical Trials
Duration:00:02:04
Phases of Clinical Trials
Duration:00:03:08
Chapter 2: Ethical Considerations in Clinical Trials
Duration:00:00:05
Introduction
Duration:00:00:29
Informed Consent
Duration:00:02:56
Institutional Review Boards (IRBs)
Duration:00:03:50
Ethical Guidelines and Regulations
Duration:00:03:49
Challenges and Considerations
Duration:00:02:43
Chapter 3: Design of Clinical Trials
Duration:00:00:32
Randomization
Duration:00:03:32
Blinding
Duration:00:02:35
Types of Control Groups
Duration:00:02:12
Sample Size Determination
Duration:00:03:08
Ethical and Practical Considerations in Trial Design
Duration:00:02:14
Chapter 4: Endpoints and Outcomes
Duration:00:00:32
Primary and Secondary Endpoints
Duration:00:04:05
Surrogate Endpoints
Duration:00:03:51
Composite Endpoints
Duration:00:06:16
Chapter 5: Patient Recruitment and Retention
Duration:00:00:36
Strategies for Recruitment
Duration:00:04:39
Retention Techniques
Duration:00:03:09
Addressing Dropouts and Non-Compliance
Duration:00:03:12
Case Studies and Examples
Duration:00:03:08
Chapter 6: Data Collection and Management
Duration:00:00:32
Case Report Forms (CRFs)
Duration:00:02:56
Electronic Data Capture (EDC)
Duration:00:04:05
Data Monitoring and Quality Control
Duration:00:04:22
Chapter 7: Statistical Methods in Clinical Trials
Duration:00:00:32
Basic Statistical Concepts
Duration:00:03:18
Hypothesis Testing
Duration:00:03:14
Interim Analyses and Data Monitoring Committees (DMCs)
Duration:00:02:49
Handling Missing Data
Duration:00:04:54
Chapter 8: Safety Monitoring and Reporting
Duration:00:00:35
Adverse Event Reporting
Duration:00:04:30
Safety Monitoring Plans
Duration:00:02:59
Regulatory Requirements
Duration:00:04:32
Chapter 9: Analysis of Clinical Trial Data
Duration:00:00:36
Statistical Analysis Plans (SAPs)
Duration:00:04:09
Intention-to-Treat vs. Per-Protocol Analysis
Duration:00:04:25
Subgroup Analyses
Duration:00:03:39
Chapter 10: Regulatory Affairs and Compliance
Duration:00:00:27
Regulatory Agencies
Duration:00:05:06
Submission and Approval Process
Duration:00:05:51
Good Clinical Practice (GCP)
Duration:00:05:03
Chapter 11: Special Topics in Clinical Trials
Duration:00:00:27
Adaptive Trial Designs
Duration:00:03:31
Pragmatic Trials
Duration:00:03:54
Patient-Reported Outcomes (PROs)
Duration:00:03:20
Precision Medicine Trials
Duration:00:04:41
Chapter 12: Reporting and Dissemination of Clinical Trial Results
Duration:00:00:32
Writing Clinical Trial Reports
Duration:00:04:48
Publishing in Peer-Reviewed Journals
Duration:00:03:08
Communicating Results to Stakeholders
Duration:00:04:00
Chapter 13: Future Directions in Clinical Trials
Duration:00:00:34
Innovations in Trial Design
Duration:00:04:08
Use of Big Data and Artificial Intelligence
Duration:00:03:27
Trends in Global Clinical Trials
Duration:00:03:37
Future Challenges and Opportunities
Duration:00:04:19