This article analyzes the dispute settlement proposals contained in the October 2020 OECD Pillar One Blueprint. We concentrate on the actual proposals found in the Blueprint and analyse them against ...critical issues that are relevant to the development of public international law dispute settlement processes more broadly, fostering a better contextualization of the analysis. Invariable, these tax disputes arise from measures taken by governments, or responses to Base Erosion and Profit Shifting (BEPS) measures by companies. In some cases, the government measures reflect deep concerns over the lack of tax revenues from foreign investors. This focus on government action has been married to corporate-centred concepts of tax certainty, leading to a 'tax certainty' design in the Blueprint that risks distorting dispute settlement in international tax for many years to come. Fortunately, the proposals leave many issues to be resolved during the drafting process set to take place over 2021-2022. This means that the international tax law regime, especially in this moment of major reform, has an opportunity to open its thinking, and its integration, into the broader corpus of public international law, as trade and investment law have done before. A failure to do so risks putting its future credibility at risk.
This article analyzes the dispute settlement proposals contained in the October 2020 OECD Pillar One Blueprint. We concentrate on the actual proposals found in the Blueprint and analyse them against ...critical issues that are relevant to the development of public international law dispute settlement processes more broadly, fostering a better contextualization of the analysis. Invariable, these tax disputes arise from measures taken by governments, or responses to Base Erosion and Profit Shifting (BEPS) measures by companies. In some cases, the government measures reflect deep concerns over the lack of tax revenues from foreign investors. This focus on government action has been married to corporate-centred concepts of tax certainty, leading to a 'tax certainty' design in the Blueprint that risks distorting dispute settlement in international tax for many years to come. Fortunately, the proposals leave many issues to be resolved during the drafting process set to take place over 2021-2022. This means that the international tax law regime, especially in this moment of major reform, has an opportunity to open its thinking, and its integration, into the broader corpus of public international law, as trade and investment law have done before. A failure to do so risks putting its future credibility at risk.
Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two ...goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated.
We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol.
When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and ...quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Imaging Findings of Vaping-Associated Lung Injury Henry, Travis S; Kligerman, Seth J; Raptis, Constantine A ...
American journal of roentgenology (1976),
03/2020, Letnik:
214, Številka:
3
Journal Article
Recenzirano
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E-cigarettes are devices that aerosolize nicotine- or cannabis-based concentrates ...mixed with other solvents and have been marketed as an alternative to cigarettes. E-cigarette use, or vaping, is increasingly popular but has not been proven to be an innocuous substitute for traditional smoking. Several patterns of vaping-associated inhalational lung injuries have been reported in the past few years. This article reviews many of the imaging patterns that have been encountered in association with e-cigarette use.
E-cigarette use is associated with a range of lung injury patterns that have only recently been recognized as use of these products continues to rise. When the radiologist sees one of these patterns of lung injury, it is important to raise the possibility of vaping-induced lung injury because cessation of vaping is an important step in treatment.
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and ...quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
Purpose of Review
We explicate the development of cystic lung disease from the deposition of protein in the lung. The protein may be in the form of amyloid or non-amyloid (typically ...immunoglobulin-associated light chains) and is usually seen in the context of three entities: idiopathic light-chain deposition disease, Sjogren’s syndrome, and clonal lymphoplasmacytic proliferative disorders. A commonly observed and distinctive feature of the circumscribed cystic spaces is the presence of internal tissue septations.
Recent Findings
The traditional causal association of lung cysts and the pathologic entity of lymphocytic interstitial pneumonitis is untenable. Instead, the development of cysts as a consequence of the degradation of lung extracellular matrix by metalloproteinases, the process initiated with the accumulation of macrophages around deposited protein, is a compelling alternative explanation.
Summary
Lung cysts may be a consequence of parenchymal protein deposition. When internal septations are present, this particular pathogenesis should explicitly be considered, and the presence of associated clinical disorders further pursued.
To the Editor:
In stating that “proponents of equipoise have characterized randomized clinical trials solely as tools to guide clinicians in making decisions about optimal medical care,” Miller and ...Joffe (Feb. 3 issue)
1
misrepresent the concept of equipoise. Equipoise motivates clinical experts to propose randomized, controlled trials to resolve uncertainties about the relative merits of interventions and affirms the ethical propriety of participating clinicians' subsequent offer of trial enrollment to particular patients as “best therapy.”
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,
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If the offer is to be cast as a “therapeutic orientation” to clinical research, it should be encouraged.
In selecting the encouraging response rates . . .
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