Clinical Trials in Breast Cancer

Being a Successful Principal Investigator at Your Institution

Course Description:

This course will introduce participants to the steps it takes to serve as a site Principal Investigator for a clinical trial. We will discuss cooperative group, industry and investigator initiative trials. Each section will start with a review of key past clinical trials. We will then expand on strategies to becoming a successful Principal Investigator for each type of trial.

Course Objectives:

At the conclusion of this course, participants should be able to:

Objective 1—Understand the Role and Responsibilities of a Principal Investigator (PI) in Cooperative Group Trials.

• Introduce the key duties of a PI, including overseeing trial protocol adherence, managing patient safety, and coordinating with multidisciplinary teams within cooperative group settings.

Objective 2—Develop Skills to Lead and Navigate Challenges in Cooperative Group Trials.

• Equip surgeons with strategies to effectively lead a cooperative group trial, covering aspects such as patient recruitment, data integrity, regulatory compliance, and collaboration with other institutions to optimize trial outcomes and contribute to impactful breast cancer research.

Objective 3—Understand the Key Responsibilities of a Principal Investigator (PI) in an Investigator-Initiated Trial (IIT). Develop Skills to Design, Implement, and Manage Investigator-Initiated Trials.

• Provide surgeons with a comprehensive overview of the PI’s role in IITs, including protocol development, securing funding, regulatory compliance, and maintaining oversight of study conduct to ensure data integrity and patient safety.
• Guide surgeons in planning and executing their own trials, focusing on protocol writing, patient recruitment strategies, data management, and overcoming common challenges unique to IITs, such as resource limitations and balancing clinical and research duties.

Objective 4—Understand the Principal Investigator’s Role and Responsibilities in Industry-Sponsored Clinical Trials. Develop Skills for Effective Collaboration with Industry Partners.

• Introduce surgeons to the specific duties of a PI in industry-sponsored trials, including regulatory compliance, maintaining protocol fidelity, managing relationships with the sponsoring company.
• Provide surgeons with strategies for successful collaboration with industry sponsors, covering aspects such as contract negotiation, managing expectations, timelines, and balancing the interests of the sponsor with ethical obligations to patients and the research community.

CME Credit Information:

This live activity has been approved for AMA PRA Category 1 Credit™. Check back for credit designation updates.

Onsite Agenda: