Clinical Trial Design

Course Description

This course identifies and discusses the basic concepts describing the design of clinical trials for demonstrating safety and efficacy for biologics, medical devices, or pharmaceutical products. It will identify, describe and discuss the similarities and differences of clinical trials between the various biomedical product segments. Students will identify and understand clinical trial nomenclature, key components of a clinical development plan and various options for the design of clinical trials. The life cycle and timeline for a clinical trial will be identified and understood.

Learning Outcomes

  • Design a Clinical Development Plan (CDP) to include the strategy and clinical development requirements for a new biologic, drug or medical device.
  • Differentiate the role and types of contributions needed from regulatory, marketing, R/D and other functional areas to develop a clinical development plan.
  • Develop key Go/No Go criteria to advance a new drug or medical device product from Phase 1 to Phase 2 to Phase 3.
  • Select milestones and assumptions that describe the time course for conduct of a typical clinical trial.


Why Choose National University?

We’re proud to be a Veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 220,000 alumni worldwide.

Four-Week Courses

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Study when and where it’s convenient for you with evening, weekend, and 100% online classes.

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Apply or transfer any time. Classes start monthly, and applications are accepted year round.

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Attend class and learn onsite at one of over 20 locations in California.

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As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.

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