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Background: Clinical trial registries were established to improve the transparency and completeness of clinical trial reporting and a number of policies have been introduced to encourage or mandate their use. While prospective trial registration has been endorsed in Australia, there is currently no legal requirement for researchers to register or communicate findings from clinical trials. There has also been, to the best of our knowledge, no analysis previously undertaken on publication rates for clinical trials performed in Australia. Aim: We aimed to determine the proportion of clinical trials that remain 'unpublished' in Victoria, Australia´s second most populous state, between 2009 and 2013. Methods: We used data reported to Cancer Council Victoria's Cancer Trials Management Scheme (CTMS) between 2009 and 2013, to identify trials that had recruited a new patient or recorded any follow-up patient activity in the specified time period. Using this data, we conducted a systematic search of ClinicalTrials.gov, the Australia and New Zealand Clinical Trials Registry (ANZCTR), PubMed and Google for records of the trial. Trial registration numbers, acronyms and scientific titles were used as primary search terms. Results were characterized by type of publication (i.e., whether it was an accredited scientific paper or other) and source location. Results: Of the trials reported to the CTMS between 2009 and 2013, 777 trials were included in this investigation; the majority (58.8%) were randomized controlled trials (RCTs). Compared with previously published findings, communication of trial results in this study was high; 70% of trials published results in an accredited scientific journal and a further 10% in alternate form, such as a conference abstract or media release. Publication rates were higher for trials with a commercial sponsor (85%) compared with trials sponsored by a cooperative group (77%). Nearly 8% of trials in this study had not been registered on an international clinical trials register. Only 39% of unregistered trials had published results. Of the registered trials, those registered on ClinicalTrials.gov were more likely to be published (86%) compared with trials listed on ANZCTR (68%). Between 2009 and 2013 , 8% of trials registered on ClinicalTrials.gov, in our data set, were terminated; 70% of these trials published results. Conclusion: Although the rate at which clinical trial findings were published in Victoria was higher in this investigation compared with equivalent overseas data, trials registered on ClinicalTrials.gov were more likely to publish results than unregistered trials or trials registered on ANZCTR. This suggests a potential need for trial registration and publication guidelines in Australia, similar to that of the United States where the requirements and procedures for submitting registration and summary result information for clinical trials on ClinicalTrials.gov have been compulsory for the last decade. [ABSTRACT FROM AUTHOR]

Background: Smoking following a diagnosis of cancer is a powerful clinical risk indicator, with known poorer health outcomes and associated health care costs. In Australia, smoking rates are higher in rural and regional areas. There are established and effective interventions to promote smoking cessation after a diagnosis of cancer yet these are not in routine practice. Aim: This protocol paper reports on a study that aims to embed evidence-based smoking cessation strategies for people with cancer who are current smokers into routine care, resulting in in system wide improvements, an implemented program and model for further dissemination. Methods: Across three rural/regional sites, and with partners Quit Victoria and Western Alliance, this study employs a variety of methodologies to embed smoking cessation support to improve outcomes for people with cancer who currently smoke. Specifically, the project will embed a system of responsibilities and training in rural and regional health services to routinely engage people with cancer who smoke in support services. The program will: · Promote routine delivery of smoking cessation care by trained oncology staff (oncologists/nurses/ allied health) · Establish referral pathways to Quitline · Correspond with general practitioners, to: i) outline the benefits of quitting in this context, ii) promote access to nicotine replacement therapy and iii) support quitting in the community. · Improve routine recording of smoking status and documentation of provision of brief intervention (personalised advice given, resources provided) and outcomes. Participants: are oncology staff and general practitioners across three health services: Ballarat Health Service, East Grampians Health Service (Ararat), Wimmera Health Care Group (Horsham), all located in Victoria, Australia. Data collection will occur across four sources: 1) Oncology staff: qualitative and quantitative data collection understanding confidence and views on provision on cessation advice; 2) Monitoring Quitline calls, 3) Interview with local general practitioners and 4) Medical record reviews to explore frequency of recording of smoking status. Data will be collected pre/postintervention. Results: The project is underway with the intervention manuals in development. The project is due for completion in 2020. Conclusion: This project takes a health services approach to integration of smoking cessation support in routine care for people with cancer in rural and regional areas. This program of work has capacity to determine best approaches to integrate smoking cessation into routine care, resulting in reduced mortality and morbidity, improved effectiveness of anticancer treatments, and reduced health care costs; by establishing internationally relevant, embedded health care interventions. [ABSTRACT FROM AUTHOR]