Publication Rate and Characteristics of Lung Cancer Clinical Trials

This is the authors' abstract. We don't add key points for this paper.

Clinical trials play a crucial role in shaping the practice of medicine.Nonreporting of clinical trial results affects the validity of the literature and can negatively affect patient care.Lung cancer is the leading cause of cancer-related mortality in the United States and worldwide.1 Studies assessing reporting of clinical trial results in thoracic oncology are lacking.We sought to investigate the publication rate among registered lung cancer clinical trials. MethodsFor this cross-sectional study, ClinicalTrials.govwas searched on August 8, 2018, to identify registered lung cancer clinical trials with a study completion date between January 1, 2000, and August 7, 2016.Interventional phase 2 or 3 trials involving patients aged 18 years or older with a recruitment status of completed or terminated were included.Using the National Clinical Trial identifier, trial title, and keywords, 3 databases were searched.PubMed and Google Scholar were searched by 2 of us independently (G.A.S. and S.F.).Another of us (C.K.) searched EMBASE for the trials found unpublished after the initial literature search.Subsequently, email queries were sent to trial investigators of unpublished completed trials.Trial results were categorized as (1) publication in a peer-reviewed journal and (2) no peer-reviewed publication (including conference proceedings and reporting of results on ClinicalTrials.gov).Logistic regression analysis was performed to assess the characteristics associated with nonpublication.Statistical analysis was performed using R statistical software version 3.4 (R Project for Statistical Computing).The date of analysis was July 15, 2019.The study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.In accordance with the policies of the Human Subject Protection Program at Georgetown University Medical Center, this study was not submitted for ethical review and did not require informed consent. ResultsA total of 1294 clinical trials were included (Figure).In all, 1038 (80.2%) were completed and 256 (19.8%) were terminated.The median (interquartile range) follow-up time after study completion or termination was 116 (81-147) months.Characteristics of completed trials are summarized in the Table.Among the 1038 completed trials, our search of the databases found that 702 (67.6%) were published and 336 (32.4%) were unpublished.Among the 336 unpublished clinical trials, we identified the contact information of trial investigators for 183 clinical trials (54.5%).We received 102 responses (55.7%); 51 reported peer-reviewed publication of their trials and 51 confirmed the nonpublication status.Overall, among the completed trials, we found that 753 trials (72.5%) were published and 285 trials (27.5%) were unpublished.Industry-sponsored trials were less likely to be published compared with those sponsored by the National Institutes of Health (odds ratio [OR], 2.27; 95% CI, 1.31-4.00)and academic institutions (OR, 1.55; 95% CI, 1.15-2.10)(Table ).Multicenter studies were more likely to be published (OR, 2.78; 95% CI, 2.08-3.73)than single-center studies.Greater patient enrollment was associated with publication (>500 participants: OR, 3.43; 95% CI, 1.83-6.64;and 100-500 participants: OR, 2.87; 95% CI, 2.08-3.73)compared with studies with fewer than 100