title: Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer.
abstract: BACKGROUND
  Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences.
  
  
  OBJECTIVE
  To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer.
  
  
  METHODS
  Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I.
  
  
  RESULTS
  KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations.
  
  
  CONCLUSIONS
  The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites.
authors.affiliation: Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Sueoka-Aragane
authors.affiliation: Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
authors.forename: Naomi
authors.initials: N
authors.lastname: Kobayashi
authors.affiliation: Radiology Department, NICE University Hospital, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Bonnard
authors.affiliation: MEDIAN Technologies, France.
authors.forename: Colette
authors.initials: C
authors.lastname: Charbonnier
authors.affiliation: Global Healthcare IT Project, Canon Inc., Japan.
authors.forename: Junta
authors.initials: J
authors.lastname: Yamamichi
authors.affiliation: Global Healthcare IT Project, Canon Inc., Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mizobe
authors.affiliation: Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Kimura
keywords: Thorax; adults; computed tomography (CT); computer applications; lung