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10 Modules / ~100 pages
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~25 Modules / ~400 pages
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Advanced Clinical Trial Design
( 25 Modules )

Module #1
Introduction to Advanced Clinical Trial Design
Overview of advanced clinical trial design concepts and importance in modern clinical research
Module #2
Review of Basic Clinical Trial Design
Refresher on fundamental concepts of clinical trial design, including parallel group, crossover, and longitudinal designs
Module #3
Advanced Randomization Techniques
Discussion of blocked randomization, stratified randomization, and adaptive randomization methods
Module #4
Covariate-Adaptive Randomization
In-depth exploration of covariate-adaptive randomization methods, including minimization and response-adaptive randomization
Module #5
Factorial Designs
Introduction to factorial designs, including 2x2 and 2k factorial designs, and their applications in clinical trials
Module #6
Fractional Factorial Designs
Analysis of fractional factorial designs, including resolution III and IV designs, and their use in clinical trials
Module #7
Response-Adaptive Designs
Discussion of response-adaptive designs, including Bayesian and frequentist approaches, and their applications in clinical trials
Module #8
Platform Trials
Introduction to platform trials, including their design, conduct, and analysis, and their applications in precision medicine
Module #9
Master Protocols
In-depth exploration of master protocols, including their design, conduct, and analysis, and their applications in oncology and other fields
Module #10
Umbrella Trials
Overview of umbrella trials, including their design, conduct, and analysis, and their applications in precision medicine
Module #11
Basket Trials
Discussion of basket trials, including their design, conduct, and analysis, and their applications in oncology
Module #12
N-of-1 Trials
Introduction to N-of-1 trials, including their design, conduct, and analysis, and their applications in rare diseases
Module #13
Pragmatic Clinical Trials
Overview of pragmatic clinical trials, including their design, conduct, and analysis, and their applications in real-world settings
Module #14
Cluster Randomized Trials
Discussion of cluster randomized trials, including their design, conduct, and analysis, and their applications in healthcare settings
Module #15
Stepped-Wedge Designs
In-depth exploration of stepped-wedge designs, including their design, conduct, and analysis, and their applications in healthcare settings
Module #16
Crossover Designs
Introduction to crossover designs, including their design, conduct, and analysis, and their applications in clinical trials
Module #17
Longitudinal Designs
Overview of longitudinal designs, including their design, conduct, and analysis, and their applications in clinical trials
Module #18
Bayesian Methods in Clinical Trials
Discussion of Bayesian methods in clinical trials, including their application in adaptive designs and decision-making
Module #19
Machine Learning in Clinical Trials
Introduction to machine learning methods in clinical trials, including their application in predictive modeling and data analysis
Module #20
Digital Health Technologies in Clinical Trials
Overview of digital health technologies in clinical trials, including their application in remote monitoring and data collection
Module #21
Ethical Considerations in Advanced Clinical Trial Design
Discussion of ethical considerations in advanced clinical trial design, including informed consent and patient privacy
Module #22
Regulatory Considerations in Advanced Clinical Trial Design
Overview of regulatory considerations in advanced clinical trial design, including FDA and EMA guidelines
Module #23
Case Studies in Advanced Clinical Trial Design
Real-world examples of advanced clinical trial designs, including successes and challenges
Module #24
Future Directions in Advanced Clinical Trial Design
Discussion of emerging trends and future directions in advanced clinical trial design, including artificial intelligence and precision medicine
Module #25
Course Wrap-Up & Conclusion
Planning next steps in Advanced Clinical Trial Design career


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