Current medical research and opinion
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Second-generation anaplastic lymphoma kinase (ALK) gene targeted tyrosine kinase inhibitors (TKIs) alectinib and brigatinib have shown efficacy as front-line treatments for ALK-positive non-small cell lung cancer (NSCLC). No head-to-head data are currently available for brigatinib vs alectinib in the ALK-TKI-naive population. ⋯ Regardless of ITC methodology, OS is comparable for brigatinib vs alectinib in patients with ALK+ NSCLC previously untreated with an ALK inhibitor.
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To examine whether QT interval shortening is an overlooked adverse event as compared to QT prolongation through a review of preclinical, clinical and post-marketing adverse event data available to the regulator for centrally and nationally authorized medicinal products. ⋯ From a regulatory perspective one cannot refute the possibility of a clinically relevant risk from QT shortening through the current testing requirements. Lack of further investigations into any potential morphological changes to the AP, or APD90 shortening beyond a specified threshold in our opinion does not fully exclude the possibility of proarrhythmic effects of active substances.
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To provide recommendations for overcoming the challenges associated with the generation and use of real-world evidence (RWE) in regulatory approvals, health technology assessments (HTAs), and reimbursement decision-making in East Asia. ⋯ We recommend approaches and initiatives that aim to drive improvements in the utilization of RWE in healthcare decision-making in East Asia and other regions. We encourage large-scale collaborations that leverage the full range of skills offered by different stakeholders. Government agencies, hospitals, research organizations, patient groups, and the pharmaceutical industry must collaborate to ensure appropriate access to robust and reliable real-world data and seek alignment on how to address prioritized evidence needs. Increasingly, we believe that this work will be conducted by multidisciplinary teams with expertise in healthcare research and delivery, data science, and information technology. We hope this work will encourage further discussion among all stakeholders seeking to shape the RWE landscape in East Asia and other regions and drive next-generation healthcare.
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Randomized Controlled Trial
Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study.
The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6-12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT. ⋯ The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors.
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Multicenter Study
Mapping author taxonomies and author criteria: good practices for thinking through complex authorship situations.
Authorship criteria can be difficult to apply in complex situations, such as multicenter clinical trials, multidisciplinary research, or manuscripts reporting the results of several studies. Authors may need additional guidance to appropriately credit their colleagues even when using existing accepted author criteria and/or contributor taxonomies to guide their decisions. Definitions and explanations of authorship by various editorial groups such as International Committee of Medical Journal Editors, the Committee on Publication Ethics, the World Association of Medical Editors, and the Council of Science Editors emphasize intellectual input and accountability. ⋯ The literature was searched for existing guidelines for authors that suggest how to apply accepted authorship criteria to activities listed in contributor taxonomies. No publication was identified that mapped specific authorship criteria to particular contributor taxonomies. Suggestions were developed to assist in differentiating activities that meet author criteria from other contributions outlined in two existing contributor taxonomies.