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Master of Advanced Studies in Precision Medicine Therapeutics in Oncology MAS in PMTO
  1. Precision Medicine Therapeutics in Oncology
  2. Curriculum
  3. Clinical Trial Drug Development in Oncology Course

Clinical Trial Drug Development in Oncology

Course Information

PMTO 214 Clinical Trial Drug Development in Oncology

  • 2 units
  • Quarter Offered: Spring
  • Instructors: Joseph Ma, PharmD, Professor, Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego; Andrew Chang, PharmD, Ph.D., Lumanity Executive Consultant, Medical Affairs Consulting; Kenneth A. Kern, M.D., Affiliate Faculty, Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego, Founder and Chief Medical Officer, Oncology Breakthrough Advisory Group, LLC

Course Description & Learning Objectives

Clinical trials of experimental therapeutics are a significant element of drug development. Current regulatory authorities require the initiation and completion of clinical trials to evaluate safety, tolerability, and efficacy. Each subtype of a clinical trial has a specific objective and/or endpoint. Precision medicine has the ability to impact traditional clinical trial design. This course will focus on the impact of precision medicine primarily on oncology and contrast with non oncologic clinical trials study design that is required and/or needed for regulatory approval for investigational agents.

This course provides an understanding of all the stages of drug development clinical trials such as:
  • Phase 0, Phase 1, drug-drug interaction, drug-food interaction, and bioequivalence trials. Genomically driven trial design and classic clinical trial design: Phase II, III and IV studies
  • Immunotherapy trial design
  • Precision prevention/interception

Learning Outcomes & Skills Acquired from the Course

Upon completion of this course, students will have a better understanding of precision medicine impact on oncology and non oncology clinical trials. Students will learn the process of drug development through specific examples of case studies to better understand the issues facing the challenges of delivering a new drug on the market.

Students will learn how to:
  • Identify outcomes and/or endpoints differences between oncology and non-oncology clinical trial types.
  • Incorporate precision medicine impact on study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas.
  • Understand the challenges and bias related to the conduct of clinical research and/or clinical trials in the era.