- Optional ½ Day Workshops | (Requires Separate Registration)
Good Clinical Practice (GCP) E6 (R2) Basics Preconference Workshop
7:30 – 8:00 Registration and Continental Breakfast
8:00 – 11:30 Good Clinical Practice (GCP) E6 (R2) Basics (Break 9:45 - 10:00)
Tammy Neseth, MA, CCRP, Senior Manager Site Services, Quantum Leap Healthcare Collaborative
This half-day workshop, which also meets the NIH requirements for GCP Training, will teach to the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.
Oncology Research Fundamentals Preconference Workshop
11:30 – 12:00 Registration and Welcome
12:00 – 1:30 Basics of Oncology Research and Protocol Review
Andrea Skafel MS, CCRP, Director, Clinical Research Support Office, UCSF Helen Diller Family Comprehensive Cancer Center
This session will provide a basic overview Oncology Research. Topics include: Cancer statistics, Oncology terminology, development of cancer, understanding cancer diagnosis, staging and grading, and what makes oncology trials unique. How to critically review a protocol concentrating on specific sections such as, the schema, primary and secondary objectives, eligibility, dosing and adverse events will also be discussed. We will discuss the how to read and then build a test schedule on the protocol provided
1:30 – 2:15 Treatment Modalities
Jasmine Grant, MEd, BhSc, CCRP, Manager, Clinical Research, Princess Margaret UHN
This session will look at the goals for cancer treatment as well as the different options available, such as surgery, radiation therapy, chemotherapy, immunotherapy and other medical treatments.
2:15 – 2:30 Break
2:30 – 3:10 Response Criteria in Oncology Research
Scott Okuno, MD, Consultant, Department of Oncology, Mayo Clinic
In this session, we will review the standard approach to response evaluation in oncology. Response Evaluation Criteria in Solid Tumors (RECIST) will be discussed as well as definitions for objective assessment of change in tumor size for use in oncology trials.
3:10 – 3:50 Adverse Events in Oncology Research
Jasmine Grant, MEd, BhSc, CCRP, Manager, Clinical Research, Princess Margaret UHN
Discuss the Common Terminology Criteria for Adverse Events (CTCAE) coding dictionary for adverse events, its use in oncology research, and challenges faced in coding. Tips on navigating the CTCAE dictionary will be discussed. Special NCI reporting requirements will also be covered.
3:50 – 4:45 Oncology Case Study
This session will be an interactive activity incorporating the information gained throughout today’s program.
4:45 – 5:15 Helpful resources and tips for a new oncology professional/Q&A
This session is an opportunity to discuss questions and answers related to the topics presented in preconference.
8:00 – 8:30 Registration and Continental Breakfast
8:30 – 8:45 Introduction to SOCRA
Susanna Sellmann, RTT, BS, CCRP, Quality Assurance Manager, Princess Margaret Cancer Center
Ms. Sellmann will provide an introduction and overview of SOCRA
8:45 – 9:00 Oncology Clinical Trials Research
Tammy Neseth, MA, CCRP, Senior Manager Site Services, Quantum Leap Healthcare Collaborative
Ms. Neseth will provide an introduction and overview of the Oncology Clinical Trials Research Conference. During this time there will be discussion to assist the faculty in getting to know our attendees and their learning objectives.
9:00 – 9:50 Regulatory Considerations in Oncology Research
Erin Lynch, MS, CCRP, Administrative Director, Clinical Trials Office, Medical College of Wisconsin Cancer Center
This session will provide an overview of regulatory requirements across the lifecycle of an oncology clinical trial. Ms. Lynch will outline concepts integral to compliant regulatory management at the site level, and discuss recently issued final and draft FDA guidance documents will be discussed.
9:50– 10:10 Break
10:10 – 11:10 Eligibility, Enrollment and Ongoing Participation from the perspective of a Study Participant
This talk will look at eligibility, enrollment and study participation from the subject’s perspective.
11:10 – 12:10 Budgeting and Staffing Oncology Trials
Joanna Hill, MBA, CCRP, Senior Director – Cancers for Research and Education, HealthPartners Institute
This talk will explore strategies to create comprehensive, realistic budgets that align with the unique demands of cancer research. It will cover the critical elements of budget development, including identifying hidden costs, accounting for complex trial protocols, and ensuring compliance with regulatory requirements. Additionally, the session will provide insights into effective negotiation techniques with sponsors, highlighting how to advocate for fair funding while maintaining collaborative relationships. Attendees will leave with practical tools to enhance financial planning and secure resources for advancing oncology research.
12:10 – 12:55 Lunch (provided)
12:55 – 1:45 Developing Sponsor-Site Partnerships: The Key to Success in Oncology Trials
Jessica Hotter, BS, Senior CRA & Early Development Leader, Bristol Myers Squibb
This presentation will delve into the strategic importance of effective collaboration between sponsors and sites in driving the success of oncology trials. By showcasing best practices and key strategies, we will illustrate how robust partnerships can accelerate trial timelines, enhance data integrity, and optimize overall outcomes. Join us to discover how fostering these critical relationships can lead to more efficient and successful clinical trials in oncology, ultimately advancing the competitive edge and innovation in the field.
1:45 – 2:45 Pharmacokinetics/Pharmacodynamics and Drug Interactions
Jeff Doi, HonBSc, BScPharm, RPh, BCPS, Clinical Trials Pharmacist, Princess Margaret Cancer Centre, UHN
Determining how drugs act within the biological system and in turn how the biological system acts on drugs are important to guide pharmaceutical development. Mr. Doi will introduce pharmacokinetic and pharmacodynamic evaluations and how they are used to characterize the dose response relationships for new drug products. In this session, an overview of the mechanisms and significance of drug-drug interactions in oncology will also be provided.
2:45 – 3:05 Break
3:05 – 4:05 Correlative Science: The Business of Quality Specimen Management
Vanessa Speers, MSc, BEd, CCRP, Senior Manager, Correlative Studies Program, Princess Margaret Cancer Centre
Ms. Speers will discuss the procurement, processing, and quality of biospecimens as it relates to the advent of personalized medicine which exponentially increased the number of biospecimens that are being collected in clinical trials. Matched with the ideology of personalized medicine, with its specialized portfolio of services, a need has been generated for a centralized specimen management program to govern the collection and processing of biospecimens. This presentation will discuss the logistics managing correlative science in detail.
4:05 – 4:25 Poster Presentations
4:25 – 5:25 Phase 1 Clinical Oncology Trials
Joyce Tungol, BS, CCRP, Senior Clinical Trial Manager, Precision for Medicine
A Phase I clinical oncology trial is the first step in testing an investigational treatment approach, as it determines a drug’s safety, dosage, tolerability, and side effects. This session will provide an overview of the importance, purpose, and objectives of Phase I clinical trials. Early phase study design, logistics/characteristics and challenges will also be discussed. Additionally, we will cover the Phase I study coordinator perspective and the common day-to-day challenges encountered in the Phase I clinical trial environment.
5:25 – 5:30 Day 1 Q&A and Discussion
8:00 – 8:30 Continental Breakfast
8:30 – 9:20 Hematologic Malignancies
Elizabeth Fitzgerald, PA-C, MMS, Physician Assistant, Mayo Clinic
Ms. Fitzgerald will review current areas of interest in hematologic studies and what is coming on the horizon. The world of malignant hematology can seem overwheling. This will be the opportunity view the basics of leukemias, lymphoma and multiple myeloma. We will also look at where we have come from and what’s next in the world of hematologic malignancies.
9:20 – 10:20 Chimeric Antigen Receptor Therapy (CAR-T) in Hematologic Malignancies
Elizabeth Fitzgerald, PA-C, MMS, Physician Assistant, Mayo Clinic
Cellular therapy, in particular CAR-T and Bispecific Antibodies is an advancing field utilizing a person’s native immune system to target cancer cells and induce cell death. This novel therapy has received FDA approval in select Hematologic Malignancies with ongoing clinical trials for further advancement as well as use in solid tumor malignancies.
10:20 – 10:40 Break
10:40 – 11:40 Basic Principles of Clinical Trial Design, Conduct and Choice of Endpoints
Sumithra Mandrekar, PhD, Professor of Biostatistics and Oncology, Mayo Clinic
This presentation will review the basic principles of clinical trials design and conduct as well as a glimpse into the future of cancer clinical trials landscape. Dr. Mandrekar will explain the importance for upfront investment in planning by the study team in terms of endpoints, databases, recruitment of participants and handling of missing data. She will provide the audience with tips on best practices when it comes to monitoring of clinical trial using real clinical trials examples.
11:40 – 12:40 Imaging in Oncology Clinical Trials
Stuart Bentley-Hibbert, MD, PhD, Division Chief, Body Imaging, Columbia University Medical Center
Dr. Bentley-Hibbert will discuss the role of imaging interpretation and updated imaging criteria clinical trials.
12:40 – 1:25 Lunch (provided)
1:25 – 2:25 Positive Developments for Proton Beam Therapy in the Cooperative Group Landscape
William Stokes, MD, Assistant Professor of Radiation Oncology, Emory University School of Medicine
More than half of all people with cancer receive radiation therapy. This session will discuss the alternative to conventional radiation therapy. Proton beam therapy uses the positively charged particles in an atom (protons) that release their energy within the tumor.
2:25 – 3:25 Minimizing Inspection Findings by Actively Incorporating Good Clinical Practices (GCP)
This session will examine common FDA findings during clinical investigator BIMO inspections. We will discuss what these findings mean and the unique challenges in Oncology studies. We will also outline ways to build in quality into the study to avoid these issues.
3:25 – 3:45 Break (with opportunity for discussion)
3:45 – 4:45 Challenges and Opportunities in Oncology Research
Daniel Anderson, MD, MPH, Principal Investigator, Metro Minnesota Community Oncology Research Consortium
Dr. Anderson will discuss challenges and opportunities for clinical research as we enter 2025. He will also discuss uncertainties regarding the future of NCI and industry funded research and opportunities for navigating these challenges.
4:45 – 4:55 Day 2 Q&A and Discussion
4:55 – 5:00 Closing Remarks and Adjournment