SMi Source Lesson Drug R&D: Clinical Statistics in Clinical Trials

  • SMi Source lesson Drug R&D: Clinical Statistics in Clinical Trials has the following microlearning topics

    • 1. The Use of Statistics in Clinical Trials and Scientific Hypothesis Testing

    2. Hypotheses

    3. Why is it Important to Control Type I Error?

    4. What is the Intent to Treat Principle?

    5. The Role of Interim Analysis

    6. How Are Sample Size Calculations Made?

    7. How to Interpret Study Results?

    8. Summary

  • Lesson Drug R&D: Clinical Statistics in Clinical Trials teaches these concepts

    • Use of Statistics in Clinical Trials, Introduction, The Use of Statistics in Clinical Trials and Scientific Hypothesis Testing

  • Lesson Drug R&D: Clinical Statistics in Clinical Trials addresses these key points

    • The Use of Statistics in Clinical Trials

    After completing this module, you should be able to:

    • Formulate a null hypothesis from the study objective 
    • Distinguish between type I and type II errors
    • Estimate the effect multiplicity has on the magnitude of type I errors
    • Define the intent-to-treat principle
    • Explain the role of interim analyses
    • Estimate how significance level and other design parameters impact sample size
    • Interpret statistical tests
    • Distinguish statistical significance from clinical relevance

    Scientific Hypothesis Testing

    • Key element of clinical trials
    • Statistical evaluation of therapeutic intervention