Module #1 Introduction to Clinical Trials Overview of clinical trials, importance, and evolution
Module #2 Ethical Considerations in Clinical Trials Ethical principles, regulations, and guidelines (e.g. Helsinki Declaration, FDA, NIH)
Module #3 Basic Principles of Clinical Trial Design Types of trials (e.g. observational, interventional, Phase I-IV), study objectives, and endpoints
Module #4 Randomization and Randomized Controlled Trials (RCTs) Types of randomization, advantages, and challenges
Module #5 Bias and Confounding in Clinical Trials Types of bias, confounding, and methods to control for them
Module #6 Sample Size Calculation and Power Analysis Methods for calculating sample size, power analysis, and justification
Module #7 Data Collection and Management in Clinical Trials Types of data, data quality, and data management systems
Module #8 Research Question and Hypothesis Development Formulating research questions, hypotheses, and objectives
Module #9 Study Population and Inclusion/Exclusion Criteria Defining the study population, inclusion and exclusion criteria, and stratification
Module #10 Intervention and Treatment Assignment Types of interventions, treatment assignment, and blinding
Module #11 Outcome Measures and Endpoints Types of outcomes, endpoints, and surrogate markers
Module #12 Clinical Trial Phases and Study Designs Phase I-IV trials, crossover, factorial, and group sequential designs
Module #13 Data Analysis in Clinical Trials Descriptive statistics, inferential statistics, and statistical modeling
Module #14 Intention-to-Treat (ITT) Principle and Per-Protocol Analysis ITT principle, per-protocol analysis, and handling missing data
Module #15 Subgroup Analysis and Interactions Subgroup analysis, interactions, and effect modification
Module #16 Safety and Adverse Event Reporting Safety monitoring, adverse event reporting, and risk-benefit analysis
Module #17 Good Clinical Practice (GCP) and Regulatory Requirements GCP guidelines, ICH guidelines, and regulatory requirements for clinical trials
Module #18 Clinical Trial Registration and Reporting Clinical trial registration, result reporting, and publication bias
Module #19 Economic Evaluation in Clinical Trials Cost-effectiveness analysis, cost-utility analysis, and budget impact analysis
Module #20 Genomic and Precision Medicine in Clinical Trials Genomic data, precision medicine, and personalized therapy
Module #21 Artificial Intelligence and Machine Learning in Clinical Trials AI and ML applications, predictive modeling, and data-driven decision making
Module #22 Real-World Evidence and Pragmatic Trials RWE, pragmatic trials, and observational studies
Module #23 Clinical Trial Simulation and Modeling Clinical trial simulation, modeling, and prediction
Module #24 Case Studies in Clinical Trial Design and Analysis Real-world examples of clinical trial design and analysis
Module #25 Best Practices for Clinical Trial Conduct Good clinical practice, trial management, and quality control
Module #26 Innovative Design and Methods in Clinical Trials Adaptive designs, basket trials, and umbrella trials
Module #27 Ethnic and Racial Diversity in Clinical Trials Importance of diversity, inclusivity, and representativeness in clinical trials
Module #28 Future Directions in Clinical Trial Design and Analysis Emerging trends, challenges, and opportunities in clinical trials
Module #29 Hands-on Exercises and Group Project Applying course concepts to real-world scenarios and group projects
Module #30 Course Wrap-Up & Conclusion Planning next steps in Design and Analysis of Clinical Trials career
