RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

Course Description

RECIST stands for Response Evaluation Criteria in Solid Tumors. The National Cancer Institute is the best resource for information, and defines RECIST criteria as “a voluntary, international standard, and not an NCI standard. They are based on a simplification of former methods (WHO, ECOG) and based on measurable disease, i.e., the presence of at least one measurable lesion.” RECIST criteria provide a way to standardize measurement of solid tumors worldwide for any clinical trials that include this data to define study endpoints.

RECIST defines and standardizes how and when subjects are seen to progress, respond or remain stable in terms of their metastatic disease burden during a course of therapy. When these criteria are not well understood at the site level or consistently followed during a trial, it can put the study endpoint data in jeopardy.

Learning Objectives

• Differentiate between RECIST 1.0 and 1.1
• Describe the components of RECIST/tumor data
• Apply how to correctly calculate disease response
• Identify and predict common trends with tumor data
• Use working knowledge of common trends to help develop Case Report Forms for oncology trials

Who Should Attend

• Clinical Research Coordinators
• Clinical Research Associates
• Clinical Team Managers
• Primary Investigators who are interested in participating in oncology clinical trials, but who do not specialize in oncology or radiology

Instructor

Vanessa Laroche, B.S., CIP, CQA, C.C.R.P.  

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-021-L99-P. Released: 3/23. 

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