The significance of the trial outcome was associated with publication rate and time to publication

• Published in: Journal of clinical epidemiology 2017-04, Vol.84, p.78-84
• Main Authors: Song, Seung Yeon, Koo, Dong-Hoe, Jung, Sun-Young, Kang, Wonku, Kim, Eun Young
• Format: Article
• Language: English
• Subjects: Advanced breast cancer; Bias; Breast cancer; Breast Neoplasms - epidemiology; Breast Neoplasms - therapy; Cancer; Clinical trials; Clinical Trials as Topic - statistics & numerical data; Clinical Trials, Phase II as Topic - statistics & numerical data; Clinical Trials, Phase III as Topic - statistics & numerical data; Confidence intervals; Databases, Factual - statistics & numerical data; Documents; Epidemiology; FDA approval; Humans; Internal Medicine; Kaplan-Meier Estimate; Periodicals as Topic - statistics & numerical data; Publication bias; Publication Bias - statistics & numerical data; Registration; Reporting; Studies; Time; Trial registration
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2017.02.009

Abstract Objectives This study aims to comprehensively assess the publication of clinical trial results and factors associated with their publication. Study Design and Setting 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