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Training

Oncology Training Programs for Clinical Research Site Staff

Foundational Clinical Research Training for Site Staff

Free Oncology Modules to Support Accurate Tumor Response Evaluation

Developed by the Clinical Imaging Team at Merck Research Laboratories, these training courses are designed to help site staff build a strong understanding of Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and its immunotherapy-adapted counterpart, iRECIST, two critical frameworks for evaluating tumor response in oncology clinical trials.

Available at no cost, these modules support consistent, accurate assessments across your oncology research team. Please note that recognition of course completion may vary by clinical trial sponsor.

 

IMPORTANT: Take a screenshot of your successful course completion certificate. Your results are NOT recorded.

 

  1. Eisenhauer EA 2009 ‘New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1)’ EJC 45: 228–247
  2. Seymour L 2017 ‘iRECIST: guidelines for response criteria for use in trials testing immunotherapies’, Lancet Oncology 18: e143–52.

RECIST Training Modules

Complete the form below for access to RECIST Training Modules.

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Free Oncology Modules to Support Accurate Tumor Response Evaluation

Developed by the Clinical Imaging Team at Merck Research Laboratories, these training courses are designed to help site staff build a strong understanding of Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and its immunotherapy-adapted counterpart, iRECIST, two critical frameworks for evaluating tumor response in oncology clinical trials.

Available at no cost, these modules support consistent, accurate assessments across your oncology research team. Please note that recognition of course completion may vary by clinical trial sponsor.

 

IMPORTANT: Take a screenshot of your successful course completion certificate. Your results are NOT recorded.

 

  1. Eisenhauer EA 2009 ‘New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1)’ EJC 45: 228–247
  2. Seymour L 2017 ‘iRECIST: guidelines for response criteria for use in trials testing immunotherapies’, Lancet Oncology 18: e143–52.

RECIST 1.1

The Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 is the most commonly used method for evaluating changes in tumor burden over time during an oncology clinical trial, and deciding whether the trial participant showed a favorable treatment response or treatment failure. It is used in most malignancies other than hematological malignancies, and has been the basis for numerous regulatory approvals. This course will explain the basic concepts and the detailed steps involved in turning assessments of medical imaging scans into clinical trial endpoints.

RECIST 1.1 for Site Personnel
RECIST Chinese SCROM
RECIST 1.1 Latin American SCROM

iRECIST

This modification of the Response Evaluation Criteria In Solid Tumors (RECIST), published in 2017, is tailored to clinical trials involving cancer immunotherapy, which sometimes causes atypical patterns of treatment response not accounted for by traditional RECIST criteria. This course starts with an assumption that the student already has a strong foundation in RECIST 1.1, and discusses the background for the modified criteria and the process of applying them to evaluating tumor changes in trial participants who appear to exhibit radiographic disease progression.

 iRECIST for Site Personnel Modified for Immunotherapy
 iRECIST Chinese SCROM
 iRECIST Latin American Spanish SCROM

Additional Training: Oncology Clinical Trial Endpoints

A strong understanding of endpoints is foundational for clinical trial staff, because they are the measurements used to determine whether a clinical trial is a success. Developed by Merck, this course defines key endpoint concepts, with a particular focus on endpoints in oncology. The course is in three parts:

  • Basic concepts and terms: objective vs endpoint vs hypothesis; primary/secondary/exploratory (and what’s co-primary vs dual primary, etc.), classical vs surrogate, objective vs subjective, composite, etc.; what kinds of things can be measured (physiological, cellular, molecular, imaging).
  • Common oncology endpoints: OS, PFS, EFS, ORR, DOR, DCR, pathologic response, eCOA; what endpoints are used in what phases of development; what is the role of oncology response criteria (e.g. RECIST, Lugano, etc.)
  • Other concepts associated with endpoints: high-level definitions and discussion of concepts like Kaplan-Meier curves, censoring, analysis population, etc.

Endpoints

English

Defines key clinical trial endpoint concepts and terms, and describes the endpoints most commonly used in oncology trials and how they are analyzed.

Run Time: 80 minutes

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