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 hypotheses and study objectives and determine population and sample size.

Learning Outcomes

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

• 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
• Understand the basic statistical considerations in the design of clinical trials
• Identify whether various scientifically sound trial designs can be effectively put into practice and potential pitfalls

Topics Include

• Local standards of practice affecting clinical trials
• Pharmacoeconomics
• Working with marketing to identify unmet medical needs
• Ethical considerations in clinical trial design

Necessary Knowledge

• To be successful in this class all students should have working knowledge of Google Workspace or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.

Additional Information

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

Professional Credit

CA BRN/LVN Credit - Provider #CEP13114