Design and Analysis of Clinical Trials
( 30 Modules )

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

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Design and Analysis of Clinical Trials ( 30 Modules )

Design and Analysis of Clinical Trials
( 30 Modules )