RT Journal Article
SR Electronic
T1 Publication rate and characteristics of industry-sponsored asthma clinical trials
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4815
DO 10.1183/13993003.congress-2020.4815
VO 56
IS suppl 64
A1 Snehal Khanolkar
A1 Ruchika Thale
A1 Madhulika Bolshete
A1 Vaibhavi Jakhetia
A1 Pravin Bolshete
YR 2020
UL http://erj.ersjournals.com/content/56/suppl_64/4815.abstract
AB Background: Publication of clinical trials despite outcomes is important for transparency.Aims and Objectives: To evaluate publication rate of industry-sponsored asthma clinical trials registered on ClinicalTrials.gov.Methods: For this cross-sectional study, ClinicalTrials.gov was searched (December 29, 2019) to identify registered interventional phase 2 and 3 clinical trials involving patients with asthma with a primary study completion/termination date between January 1, 2000 and December 31, 2017. Publication of results in peer-reviewed journals was noted by searching in PubMed or by hand search.Results: A total of 626 trials were included (completed, n=584; results posted, n=287; >500 participants, n=264; completed after 2010, n=318; phase 3, n=315; randomized, n=565). Of the 626, 317 (50.6%) trials were published. Of the completed trials 52.9% and of terminated trials 19.0% were published. Among trials with and without results 63.4% and 39.8%; trials with <500 and >500 participants, 46.7% and 56.1%; and trials completed ≥2011 and ≤2010, 56.3% and 44.8%, respectively, were published (Figure). Phase of the study (2 or 3) and randomization were not associated with publication.Conclusion: Results suggested that around half of the industry-sponsored asthma clinical trials were published. Completion of trials, trials with results, a higher number of participants and duration of completion was associated with publication. FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4815.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).