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Summary: Background. Previous research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives. To examine the clinical trial evidence supporting new targeted cancer drugs' initial and supplementary indication approval in the US, EU, Canada, and Australia. Data and Methods. 25 cancer drugs across 100 indications were identified with FDA approval between 2009–2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ2-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI). Results. Out of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07–6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38–8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17–5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14–30.65], p < 0.05) than supplementary indications. Initial indications' pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93–0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09–0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01–1.39], p < 0.05). Conclusions. Targeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication's differential clinical and economic value. [ABSTRACT FROM AUTHOR]

Little is known about the types of work accommodations and natural supports that are useful for people experiencing severe mental illness working in social businesses. We conducted an exploratory, descriptive and cross-sectional investigation in Australia, Canada and Italy to study the nature of work accommodations and natural supports available in social businesses. Study findings are drawn from survey responses of a convenience sample of 90 employees with self-reported psychiatric disabilities. Results showed that, regardless of the country, social businesses provide many work accommodations and natural supports, especially those linked to schedule flexibility and support, while work accommodations related to training and schedule flexibility were linked to longer job tenure. Overall, this study advances our knowledge about the spectrum of work accommodations and natural supports that are available in social businesses for people with severe mental illness. Also, it highlights the type of work accommodations that are likely to support this population to sustain employment. [ABSTRACT FROM AUTHOR]

Introduction: Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys autoinjector compared to the currently available marketed Enbrel MYCLIC autoinjector (Australia) and Enbrel SureClick autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy.Methods: Patients (N = 191) reporting a diagnosis of RA and nurses and rheumatologists (N = 90) with experience managing RA were shown how to use Brenzys and Enbrel autoinjectors (in counterbalanced order between participants), then they used each autoinjector by injecting into a pad simulating skin, and completed a questionnaire. Study sessions took place in Australia and Canada.Results: A binomial test showed that significantly more patients indicated that the Brenzys autoinjector was easier to use than the Enbrel autoinjector (79% reporting Brenzys easier to use; p < 0.001, two-sided, 95% CI [73%, 85%]). In addition, significantly more nurses and rheumatologists with experience managing RA also indicated that the Brenzys autoinjector was easier to use (86%; p < 0.001, two-sided, 95% CI [77%, 92%) and that they would recommend the buttonless Brenzys autoinjector over the Enbrel autoinjector to patients (83%; p < 0.001, two-sided, 95% CI [74%, 90%]). Almost all patients who reported past experience using an Enbrel autoinjector (N = 17) reported on the basis of using the two devices in the study that they would prefer to switch their device to the Brenzys autoinjector rather than continue their course of therapy using the Enbrel autoinjector (16/17, 94%, 95% CI [71%, 100%]).Conclusion: On the basis of the study results, the Brenzys autoinjector was rated statistically significantly easier to use, and was overall preferred by patients and healthcare professionals with experience managing RA patients.Funding: Merck & Co., Inc. [ABSTRACT FROM AUTHOR]

Canada and Australia although geographically distant have similarities in human geography and history. Each has had a national mental health policy for some years, but Australia has driven policy implementation in this area harder than has Canada. Comparable epidemiological surveys from Australia in 1997 and Canada in 2002 allow us to explore relative rates of mental disorders and compare estimates of access to care from mental health services. We compare findings from the Australian National Survey of Mental Health and Wellbeing (1997) with those from the Canadian Community Health Survey on Mental Health and Well Being, cycle 1.2 (2002). Differences in prevalence rates and in service utilisation emerge between the two countries: Anxiety Disorders are estimated as almost 2% higher in Canada than in Australia while there is suggestion that Major Depressive Disorder, Alcohol Dependence and Drug Dependence may be more prevalent in Australia. More of the people with co-morbid disorders in Australia than in Canada make use of mental health services and a finding of marginal significance suggests that this may be true across all disorders. Causation cannot be determined from this study but possible explanations for differences in prevalence include changes in global economic, political and security contexts and concerns between 1997 and 2002 and the possible role of greater availability of alcohol in Australia. The findings also provide encouragement that strenuously implementing a national mental health policy may have been of benefit to people with mental health problems in Australia. [ABSTRACT FROM AUTHOR]

The purpose of our study was to compare various aspects of radiology training schemes in ten countries. A questionnaire was sent to senior residents in the UK, USA, Canada, Australia, New Zealand, Italy, Egypt, India, Malaysia and Greece. The questions concerned length of training, required pre-training experience, the organization of the training scheme, teaching, resources, stages at which residents can independently perform and report examinations, fellowships, and progression to jobs. A wide variety of training, ranging from highly scheduled programs with detailed aims and objectives, to self-learning occurs across the world. Examinations and assessments are also variable. There are lessons to be learned from varying practices; more exchanges of ideas should be encouraged. In view of the "internationalization" of radiology services and the variation in training styles an international qualification for quality assurance purposes may be desirable. [ABSTRACT FROM AUTHOR]