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Uncover This Tech Term: Independent Central Image Reading

  • Sang Eun Won (Asan Image Metrics, Clinical Trial Center, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Sinae Kim (Asan Image Metrics, Clinical Trial Center, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Chong Hyun Suh (Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Hyo Jung Park (Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Kyung Won Kim (Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine)
  • Received : 2023.08.11
  • Accepted : 2023.09.02
  • Published : 2023.11.01

Abstract

Keywords

References

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  2. United States. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research. Clinical Trial Imaging Endpoint Process Standards: Guidance for Industry [accessed on July 26, 2023]. Available at: https://www.fda.gov/regulatory-information/search-fdaguidance-documents/clinical-trial-imaging-endpoint-processstandards-guidance-industry
  3. Beaumont H, Iannessi A, Wang Y, Voyton CM, Cillario J, Liu Y. Blinded Independent Central Review (BICR) in new therapeutic lung cancer trials. Cancers (Basel) 2021;13:4533
  4. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247 https://doi.org/10.1016/j.ejca.2008.10.026
  5. Hyung J, Kim I, Kim KP, Ryoo BY, Jeong JH, Kang MJ, et al. Treatment with liposomal urinotecan plus fluorouracil and leucovorin for patients with previously treated metastatic biliary tract cancer: the phase 2b NIFTY randomized clinical trial. JAMA Oncol 2023;9:692-699 https://doi.org/10.1001/jamaoncol.2023.0016