totality of evidence
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Immunotherapy ◽  
2021 ◽  
Author(s):  
Enrico Fusaro ◽  
Patrick Durez ◽  
Johannes Wohlrab ◽  
Soohyun Lee ◽  
SangWook Yoon ◽  
...  

Biosimilars can reduce healthcare costs and expand patient access to biologic therapies. Currently, eight adalimumab biosimilars have received regulatory approval from the EMA and/or the US FDA. Following recent EMA approval of the first high-concentration adalimumab biosimilar, CT-P17, this review provides a contemporary update on adalimumab biosimilars currently licensed in Europe and the USA. The totality of evidence from each clinical development program is summarized, and characteristics of each formulation and/or device that potentially affect the convenience of treatment for patients are discussed. Future perspectives are considered, including the potential impact of the FDA’s first interchangeability designation for an adalimumab biosimilar, ahead of their entry into the US marketplace in 2023.


Author(s):  
Walter Reinisch ◽  
Stanley Cohen ◽  
Monica Ramchandani ◽  
Majed Khraishi ◽  
Jennifer Liu ◽  
...  
Keyword(s):  

Author(s):  
Sabine Guth ◽  
Stephanie Hüser ◽  
Angelika Roth ◽  
Gisela Degen ◽  
Patrick Diel ◽  
...  

AbstractSince the addition of fluoride to drinking water in the 1940s, there have been frequent and sometimes heated discussions regarding its benefits and risks. In a recently published review, we addressed the question if current exposure levels in Europe represent a risk to human health. This review was discussed in an editorial asking why we did not calculate benchmark doses (BMD) of fluoride neurotoxicity for humans. Here, we address the question, why it is problematic to calculate BMDs based on the currently available data. Briefly, the conclusions of the available studies are not homogeneous, reporting negative as well as positive results; moreover, the positive studies lack control of confounding factors such as the influence of well-known neurotoxicants. We also discuss the limitations of several further epidemiological studies that did not meet the inclusion criteria of our review. Finally, it is important to not only focus on epidemiological studies. Rather, risk analysis should consider all available data, including epidemiological, animal, as well as in vitro studies. Despite remaining uncertainties, the totality of evidence does not support the notion that fluoride should be considered a human developmental neurotoxicant at current exposure levels in European countries.


Author(s):  
Sherod Thaxton

The price of capital trials, appeals, and clemency proceedings have skyrocketed since the U.S. Supreme Court lifted its moratorium on the death penalty, but this has not translated to more reliable case outcomes—the rate of serious reversible error and wrongful convictions has steadily increased during the same time period. The overly aggressive use of the death penalty by prosecutors has not only been convincingly linked to these high reversal rates, but may also increase crime, decrease the likelihood of arrests for homicides, and lead to heightened risks of miscarriages of justice for non‐capital defendants. It follows that limiting hawkish prosecutorial decision‐making in potentially capital cases may be particularly effective in reducing the prevalence of error and reducing unnecessary expense. Curbing the virtually unfettered discretion of prosecutors is not a new idea, but extant proposals tend to suffer from shortcomings that are likely to render them impractical or ineffective. Any viable legal intervention must increase prosecutorial accountability for inadequate charge‐screening in capital cases while still permitting prosecutors to retain discretion in seeking the death penalty. This essay describes a reform that consists of two primary components: (1) an advisory (i.e., non‐binding) opinion from a reviewing authority assessing the appropriateness of a prosecutor’s decision to seek the death penalty in a case based on the totality of evidence, and (2) financial and administrative cost-shifting mechanisms capable of disincentivizing prosecutorial overreaching in capital charging.


2021 ◽  
Vol 3 ◽  
pp. 27
Author(s):  
Mairéad Conneely ◽  
Katie Robinson ◽  
Siobhán Leahy ◽  
Dominic Trépel ◽  
Fionnuala Jordan ◽  
...  

Background: Older adults are frequent users of Emergency departments (ED) and this trend will continue due to population ageing and the associated increase in healthcare needs. Older adults are vulnerable to adverse outcomes following ED discharge. A number of heterogeneous interventions have been developed and implemented to improve clinical outcomes among this cohort. A growing number of systematic reviews have synthesised evidence regarding ED interventions using varying methodologies. This overview aims to synthesise the totality of evidence in order to evaluate the effectiveness of interventions to reduce adverse outcomes in older adults discharged from the ED. Methods: To identify relevant reviews, the following databases will be searched: Cochrane Database of Systematic reviews, Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Databases of Abstracts of Reviews of Effects, PubMed, MEDLINE, Epistemonikos, Ageline, Embase, PEDro, Scopus, CINAHL and the PROSPERO register. The search for grey literature will include Open Grey and Grey Literature Reports. Systematic reviews of randomised controlled trials will be analysed to assess the effect of ED interventions on clinical and process outcomes in older adults. Methodological quality of the reviews will be assessed using the Assessment of Multiple Systematic Reviews 2 tool. The review will be reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Summary of findings will include a hierarchical rank of interventions based on estimates of effects and the quality of evidence. Discussion: This overview is required given the number of systematic reviews published regarding the effectiveness of various ED interventions for older adults at risk of adverse outcomes following discharge from the ED. There is a need to examine the totality of evidence using rigorous analytic techniques to inform best care and potentially develop a hierarchy of treatment options. PROSPERO registration: CRD42020145315 (28/04/2020)


2021 ◽  
Vol 45 (1) ◽  
pp. 1-26
Author(s):  
David Gough

For research evidence to inform decision making, an appraisal needs to be made of whether the claims are justified and whether they are useful to the decisions being made. This chapter provides a high level framework of core issues relevant to appraising the “fitness for purpose” of evidence claims. The framework includes (I) the variation in the nature of research, the evidence claims it produces, and in the values, perspectives, and ethical issues that underlie it; (II) the main components of the bases of evidence claims in terms of (i) how relevant evidence has been identified and synthesized to make a claim, (ii) the technical quality and relevance of the included evidence, and (iii) the totality of evidence to justify the warrant of the evidence claim (including the potential for there to be alternative explanations); (III) evidence standards to appraise evidence claims and examples of guides and tools to assist with aspects of such appraisal; and (IV) engagement with evidence: (i) the communication of evidence claims, (ii) the fitness for purpose of these evidence claims for decision makers, and (iii) and the interpretation of such claims to provide recommendations and guidance.


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