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Science of Clinical Trials Design

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About This Course

This course reviews the science that forms the basis of effective clinical trial design. You’ll learn to classify and describe trial design by stage in drug and device development. The course covers the purposes of clinical trials, including types of trial designs. You'll learn to define hypothesis and study objectives and determine population and sample size.

Additional topics include:

  • Study procedures
  • Stopping rules
  • Basic protocol
  • Local standards of practice affecting clinical trials
  • Safety information measures
  • Scientific and ethical considerations
  • Validity of design, execution, analysis and reporting
  • Pharmacoeconomics
  • Merging phases for economic and marketing purposes
  • Multiple endpoints
  • Working with marketing to identify unmet medical needs

You'll gain hands-on experience designing clinical trials synopses and Phase 2 development strategies.


Professional Credit: CA BRN/LVN Credit - Provider #CEP13114.

Learning Outcomes

At the conclusion of the course, you should be able to:

  • Understand the purposes of clinical trials
  • List and describe the drug and device clinical trial phases
  • Describe various types of clinical trial designs and their application
  • Explain how goals and objectives of a clinical trial are established
  • Describe the ethical considerations in the design of clinical trials
  • Explain how local standards of care affect the design of clinical trials
  • Understand the basic statistical considerations in the design of clinical trials
  • List and describe the key elements of a protocol
  • Identify whether various scientifically sound trial designs can be effectively put into practice and potential pitfalls
  • Interpret clinical trial results

Skills You'll Gain

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