10-Week Conducting and Managing Oncology Clinical Trials (Jun 29 - Aug 31, 2023)

10-Week Conducting and Managing Oncology Clinical Trials is organized by Barnett International and will be held from Jun 29 - Aug 31, 2023.

Course Description:
This 10-Week series provides an in-depth look at how oncology trials are conducted and how they differ from other clinical trials. For example, oncology can be more difficult due to the complexity of the disease and its treatments, the number of prior therapies, the proper staging of the disease, and other criteria for trial eligibility. Each module will address a specific oncology knowledge area to improve the clinical researcher’s knowledge. This course is for the clinical research professional who is either in oncology clinical research seeking education to improve their understanding of oncology trials or for those who would like to enter the field or who are assigned to these trials but who have little or no experience in oncology trials.

The resources required to take this online course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives:
• Define best practices for understanding the oncology trial, including the basics of phase I, phase II, and phase III trials
• Identify the parts of an oncology protocol and types of therapies used in oncology trials
• Define the future new agent therapies in cancer research and the role of traditional therapies
• Define and compare RECIST 1.1, iRECIST, and PERCIST
• Examine why adjudication of tumor assessment is used in oncology clinical trials
• Examine challenges in adverse event reporting: Common Terminology Criteria for Adverse Events (CTCAE)
• Identify how the clinical researcher plays a significant role in the field of oncology research

Course Outline:
• Module 1: Design and Conduct of Oncology Trials: From Non-Clinical Through Pivotal Trial Phases
• Module 2: The Oncology Protocol: Dissection of the Protocol for Better Understanding, Training, and Compliance/Adherence By Research Teams
• Module 3: Defining Types of Therapies: Adjuvant, Neoadjuvant, Maintenance, and the Rationale for Combination Therapy; Use of Surgical or Radiation Therapy in the Treatment of Cancers
• Module 4: Understanding Future New Agent Therapies in Cancer Research and Some that are Already Here: The Future of Immunotherapy and Beyond While Maintaining the Role of Traditional Therapies
• Module 5: Oncology Endpoints: Making Sure Everyone Understands How, When, and Why Endpoints Matter, What the Path to Approval Is, and What the New Approval Designations Mean
• Module 6: Understanding Why RECIST 1.1, iRECIST, or PERCIST is Being Used in the Clinical Trial You Are Assigned/Manage
• Module 7: Adverse Event Reporting in Oncology Clinical Trials: Considerations for Successful Adverse Event Reporting the Importance of CTCAE
• Module 8: Understand Oncologic Emergencies, Supportive Care, and Alternative/Complementary Medicine and How These Contribute to or Cause Adverse Events
• Module 9: Recruitment Challenges: Define the Challenges and Methods for Improvement, Including the Role and Effect of Expanded Access Programs and Investigator-Initiated Trials
• Module 10: Putting It All Together and the Role of the Clinical Researcher. How Your Role Impacts the Outcome of Clinical Trials and What Can You Do to Improve the Outcome