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Course Description

This course will cover the basic concepts of clinical research and cancer clinical trials, the purpose of ethics in research, clinical trial study design, and information about informed consent. A description of the types of clinical research studies that are conducted will also be included.

Course Outline

Topics to include:

  1. Introduction to Clinical Trials
  2. Basic Concepts of Clinical Research, Purpose of Ethics in Research, Informed Consent, 5 Most Common Study Designs
  3. Cooperative Groups and Pharmaceutical Trials
  4. Investigator Initiated Studies
  5. Survivorship and Supportive Care Trials

Learner Outcomes

  1. Introduction to Clinical Trials
  • Learn definitions and terminologies
  • Learn the importance, types, and phases of cancer clinical trials
  • Learn the Role of UH Cancer Center
  1. Cooperative Groups and Pharmaceutical Trials
  • Learn about different types of trials, including federally-sponsored cooperative group trials and industry-sponsored trials
  • Gain knowledge about drug development processes, sources of new drugs and devices, the process of discovery, how discovery becomes a drug or device
  1. Investigator-Initiated Studies
  • Learn the regulatory considerations in conducting Investigator-Initiated Studies
  1. Survivorship and Supportive Care Trials
  • Define and describe the role of supportive oncology care
  • Gain knowledge in symptom management, coordination of care, and advanced care planning
  1. Clinical Research Journal Club #2
  • Understand how to interpret and analyze published articles on clinical research topics

Applies Towards the Following Certificates or Series

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