Program Description

Oncology Clinical Trials Conference

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist Research Professionals in improving their skills and their understanding of the responsibilities of conducting oncology clinical research.

Objective: The goal will be accomplished through lecture and practical application facilitated by clinical research professionals. Information will be presented and discussed regarding the administration of oncology clinical trials according to regulation, guidance, policy and procedure.

GCP E6 (R2) Basics Preconference Workshop:

This preconference half-day workshop, which also meet 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:

The conference will feature an optional half-day preconference workshop on Oncology Fundamentals. This preconference is designed to provide a comprehensive overview of the fundamentals of working in Oncology Research and complements the Main Program. This interactive workshop will provide you with an overview of the oncology therapeutic area and examine why oncology trials are unique.

Learning Objectives – GCP E6 (R2) Basics Preconference Workshop

The participant will be able to:

Discuss principles of ICH Good Clinical Practice (GCP) E6 (R2)

Learning Objectives – Oncology Research Fundamentals Preconference Workshop

The participant will be able to:

Discuss oncology research basics including cancer statistics, oncology terminology, development of cancer, understanding cancer diagnosis, and staging and grading trends in oncology
Discuss the use of Response Evaluation Criteria in Solid Tumors (RECISIT)
Understand how to read and evaluate oncology protocols

Learning Objectives - Main Conference

Upon completion of this course the attendee should be able to:

Discuss current trends in oncology clinical research and identify how these trends are influencing oncology trials.
Discuss the challenges of conducting oncology clinical research
Discuss the complexity of oncology trials and tools and techniques for managing these trials
Discuss regulatory requirements for oncology research including the NCI policies and guidelines for protocol development
Discuss the basic principles of clinical trial design
Discuss the standard approach to response evaluation in oncology
Describe sponsor expectations of oncology research sites
Discuss site selection from pre-qualification through initiation and site ready status
Describe the importance of Pharmacokinetics (PK) evaluations in oncology research
Discuss the use of personalized medicine and target therapies in oncology research
Describe the process of reporting adverse events, including special NCI reporting requirements
Discuss the standard approach to response evaluation in oncology research
Discuss the Investigator’s responsibilities for conducting safe, ethical, and successful research
Discuss the changing methodology used for conducting Phase 1 oncology trials
Discuss the process for identifying outcome measures in oncology research studies
Discuss Immunotherapy as an emerging class of cancer treatment that uses the body’s own immune system to help fight cancer cells
Discuss common FDA findings, what these findings mean, and the unique challenges they present in Oncology studies