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Basic Statistical Principles: Validity and Sample Size is a Course

Basic Statistical Principles: Validity and Sample Size


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Full course description

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute - SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Program Description:

The fundamental principles of statistics, including hypothesis testing, power, multiplicity, mathematical and data adjustments, and statistical confidence will be discussed. These principles applied to study design inform clinical endpoints, sample size, biases, validity, and missing data. At the end of this program the learner will:

  • Understand basic statistical principles relate to clinical research and how they affect clinical trial practices and study design.
  • Differentiate between statistical and clinical significance.
  • Evaluate different types of endpoints, e.g., continuous, ordinal, binary, survival, composite, surrogate)
  • Identify factors leading to missing data and biases and statistical techniques utilized to manage these factors. 


Course Topics

  1. Statistical Inference
  2. Hypothesis Testing
  3. Statistical Significance and Clinical Significance
  4. Power and Sample Size
  5. Randomization and Blinding
  6. Estimates and Confidence Intervals
  7. Multiplicity and Approaches for Multiplicity Adjustments
  8. Regulatory Claims
  9. Multiple Endpoints vs. Co-Primary Endpoints
  10. Different Types of Endpoints
  11. Clinical and Surrogate Endpoints
  12. Missing Data and Bias