Randomization Process and Unblinding for Analysis

Clinical trials are literal information factories and the data obtained from them must be accurate, reproducible, and generalizable to the population being studied, hence researchers know to exclude bias as much as possible. Randomization and Blinding are two tools that help to make a study more credible. Randomization puts subjects into test groups randomly and Blinding prevents a set of participants in the study from identifying which subjects are on which treatments. This course introduces participants to these concepts and walks them through the types and how to use them. You will also learn about unblinding, which is the opposite of blinding and is used to provide insight into the clinical efficacy of an investigational drug.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Randomization – Definition and Importance

• What is Randomization?
• Why is it Necessary?
• Is It Ethical?
• Randomization Techniques

Lesson 2: Randomization Techniques: Simple Randomization & Unequal Allocation

• Simple Randomization
• Unequal Allocation

Lesson 3: Randomization Techniques: Block & Stratification

• Block Randomization
• Stratified Randomization

Lesson 4: Adaptive Randomization Technique

• What is Adaptive Randomization?
• Minimization
• Response-adaptive Randomization

Lesson 5: Blinding

• What is Blinding?
• Why is it Necessary?
• Types of Blinding

Lesson 6: Unblinding

• What is Unblinding?
• Unblinding for Analysis
• Documentation

Glossary

Conclusion

Quiz