Mar 09, 2021

Web seminar: Guidelines on imaging evaluation criteria for clinical trials of anti-tumor drugs published in China

On January 15, 2021, China CDE (Center for Drug Evaluation) published guidelines on image evaluation criteria for anti-tumor drug clinical trials. In recent years, a large number of clinical trials related to anti-cancer drugs have been conducted in China, and the number of clinical trials that use medical imaging evaluation from the early development stage is on the rise.

We are pleased to announce that our partner CRO in China, Proswell Medical Company, has invited Professor Ukihide Tateishi of Tokyo Medical and Dental University to present a web seminar at Proswell University. In this seminar, we will compare the CDE guidance and  the Clinical Trial Imaging Endpoint Process Standards Guidance for Industry released by the US FDA in 2018, and explain the importance of standardization in imaging trials with our experience.

 

Date:

March 16, 2021 (Tue) 16:00-17:00 JST (15:00-16:00 BST)

 

Speakers:

Ukihide Tateishi, MD, PhD, Professor at Department of Diagnostic Radiology, Tokyo Medical and Dental University

Zheng Tong, Department of Image Analysis Micron, Inc.

 

Agenda:

Part 1. Interpretation of the CDE guidelines – with reference to Micron’s efforts in Japan　

  1. Use of Independent Review Committees
    • Comparison between FDA guidance and CDE guideline
    • What are the benefits of using independent central review?
    • IRC case example
  2. Design of Independent Review Process and Timing of Evaluation
    • Study design
    • Image data review method
    • Evaluation timing
  3. Criteria for imaging endpoints
    • Comparison of public comments version and official version
    • Determination of evaluation criteria
  4. Use of FDG-PET
    • Comparison of public comments version and official version
    • Standardization of qualitative and quantitative evaluations

 

Part 2: Standardization of PDG-PET / CT

  1. Procedures and Criteria for Standard FDG-PET/CT: Recent Progress

　　RSNA-QIBA (RSNA-Quantitative Imaging Biomarler Allegiance)

　　JRS-QIBA (Japan Radiologic Society-QIBA)

　　JSNM WG (Japanese Society of Nuclear Medicine-Tateishi Working Group)

  1. Approved Clinical Trial of Asian Multicenter Phase-II in Cooperation with MICRON Inc.

 

Fee:

Free of charge. Advance registration through Proswell Medical Company’s WeChat site is required.

 

Part 1 will be conducted in Chinese and Part 2 in English. No Japanese interpretation will be provided.

 

How to register and other details

Please refer to the following Proswell Medical Company website.

https://www.proswell.com.cn/post.html?id=604048d21cca8a09123c67f7

 

 

Micron, Inc. has entered into a business alliance agreement with Proswell Medical Company. To mark this alliance, one of our employees will be speaking at their web seminar called “Proswell University.” (Note: This seminar will be in Chinese.)

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