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RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials June 2011

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. 

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Learning Objectives

  • Differentiate between RECIST 1.0 and 1.1
  • Describe the components of RECIST/tumor data
  • Correctly calculate TRG disease response
  • Identify and predict common trends with tumor data
  • Use working knowledge of common trends to help develop CRFs 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

Jackie Earabino, R.N., B.S.N.

Click here for complete trainer biographies 

Course Length Time

2 hours; 1:00 – 3:00 p.m. Eastern

Course Dates

June 14, 2011

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471
 

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CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

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