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.