Data Management & Oncology Trials

2 part webinar
60-minute presentation followed by 30-minute Q&A

Overview

This session will provide an update on the status of the Common Terminology Criteria for Adverse Events (CTCAE) revision project and will describe participation of the stakeholders and the ongoing CTCAE governance, maintenance, and MedDRA compliance. Evaluation of oncology clinical trial objectives will be discussed from the point of view of the clinical data manager with respect to clinical trial endpoints, response evaluation and toxicity. In addition, time to event analysis, one of the most prevalent analytical methods in oncology, will be reviewed with respect to clinical data management.

Learning Outcomes/Objectives

  1. Describe historical and current use of CTCAE in oncology clinical trials.
  2. Summarize features of revised CTCAE and MedDRA compliance.
  3. Describe how RECIST is used to assess disease response in oncology clinical trials.
  4. Identify critical data elements for the most commonly used oncology clinical trial endpoints.
  5. Evaluate the quality of response and toxicity data.
  6. Describe the basic concepts of and identify data elements required for time to event analysis.

Presenters

Elizabeth Ness, B.S.N., M.S., is Director of Staff Development at the National Cancer Institutes’ Center for Cancer Research (CCR). She oversees the training and professional development of staff supporting approximately 275 ongoing protocols that are conducted at the NIH's Clinical Research Center.

Tim Breen Ph.D., M.S., CCDM., is Biostatistics Project Coordinator, Division of Biostatistics, Indiana University School of Medicine. He coordinates statistical data management for the Indiana University Simon Cancer Center and the Hoosier Oncology Group.

Target Audience

CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians, and project managers working within the clinical trials industry.

Continuing Education Credit Opportunity

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.  Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.