title: The significance of the trial outcome was associated with publication rate and time to publication.
abstract: OBJECTIVE
  This study aims to comprehensively assess the publication of clinical trial results and factors associated with their publication.
  
  
  METHODS
  Phase II and III trials of advanced breast cancer registered on ClinicalTrials.gov between October 1, 2000, and September 30, 2012, were identified. Publications were searched by using PubMed and reviewing those listed on the registry site. The main outcomes were publication rate, public availability of results, and time to publication.
  
  
  RESULTS
  Of 352 phase II and 74 phase III trials, 12.5% and 31.1% were published, whereas 46.9% and 58.1% had publicly available results, respectively. Compared to those with significant results, studies with nonsignificant results had delays in time to publication (P < 0.001). Even after adjusting for funding source and phase type, the significance of study outcomes was a significant factor that affected time to publication (hazard ratio = 6.02; 95% confidence interval: 3.59, 10.07; P < 0.001), with trials with significant outcomes taking less time to publish than those with nonsignificant outcomes.
  
  
  CONCLUSIONS
  Underreporting of results and nonpublication or delays in the publication of negative results were identified in registered trials of advanced breast cancer. Thus, further initiatives appear necessary to urgently address such publication bias.
authors.affiliation: Clinical Research Lab, Department of Health Science and Clinical Pharmacotherapy, Chung-Ang University College of Pharmacy, PO Box 06974, Seoul, Republic of Korea.
authors.forename: Seung Yeon
authors.initials: SY
authors.lastname: Song
authors.affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, PO Box 03181, Seoul, Republic of Korea.
authors.forename: Dong-Hoe
authors.initials: DH
authors.lastname: Koo
authors.affiliation: College of Pharmacy, Chung-Ang University, PO Box 06974, Seoul, Republic of Korea.
authors.forename: Sun-Young
authors.initials: SY
authors.lastname: Jung
authors.affiliation: College of Pharmacy, Chung-Ang University, PO Box 06974, Seoul, Republic of Korea.
authors.forename: Wonku
authors.initials: W
authors.lastname: Kang
authors.affiliation: Clinical Research Lab, Department of Health Science and Clinical Pharmacotherapy, Chung-Ang University College of Pharmacy, PO Box 06974, Seoul, Republic of Korea; College of Pharmacy, Chung-Ang University, PO Box 06974, Seoul, Republic of Korea. Electronic address: ginny7kim@naver.com.
authors.forename: Eun Young
authors.initials: EY
authors.lastname: Kim
mesh_terms: D001943:Breast Neoplasms / Q000453:epidemiology / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D016208:Databases, Factual / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D010506:Periodicals as Topic / Q000706:statistics & numerical data*; D017594:Publication Bias / Q000706:statistics & numerical data*; D013995:Time
keywords: Advanced breast cancer; Clinical trials; Publication; Publication bias; Reporting; Trial registration