title: Current Status and Challenges of Cancer Clinical Trials in Korea.
abstract: OBJECTIVE
  Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems.
  
  
  METHODS
  We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals.
  
  
  RESULTS
  The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and forty-four clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials.
  
  
  CONCLUSIONS
  The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
authors.forename: Byoung Yong
authors.initials: BY
authors.lastname: Shim
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
authors.affiliation: Divison of Hematology-Oncology, Department of Medicine, Dankook University College of Medicine, Cheonan, Korea.
authors.forename: Soonil
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jin-Soo
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
authors.forename: Kyoung Eun
authors.initials: KE
authors.lastname: Lee
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Myung-Ju
authors.initials: MJ
authors.lastname: Ahn
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000191:economics / Q000458:organization & administration / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000191:economics / Q000706:statistics & numerical data; D009369:Neoplasms / Q000628:therapy*; D056910:Republic of Korea; D012108:Research Personnel; D012109:Research Support as Topic / Q000191:economics / Q000706:statistics & numerical data
keywords: Clinical trial; Investigator-initiated clinical trial; Sponsor-initiated clinical trial