10-Week Conducting and Managing Oncology Clinical Trials

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, number of prior therapies, or 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.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. 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

Who Should Attend

• Clinical Project Managers/Clinical Project Leaders
• Clinical Trial Managers
• Clinical Operations Managers
• Clinical Safety Team Personnel
• Clinical Research Associates
• Clinical Research Coordinators
• Clinical Trial Assistants
• Data Managers
• Clinical Research Personnel seeking to learn about oncology clinical trials

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

The course will be led by one of the following instructors:

Denis R. Miller, M.D.

Linda Patricia Miller, M.D.

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$2,295 by Early Bird Deadline

$2,495 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-041-L99-P. Released: 9/23.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.