A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. Setting: USA, the EU, India and South Africa. Main outcome measures: Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. Results: A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa. Conclusions: Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population.

The designation of documentary types, series and units in Spain. A contribution to archival theory (2).

The identification of archival records depends on description, being this last process summed up in designation. The title given to dif-ferent groups of documents will have a great incidence in archival func-tions. Taking this premise as our starting point, this paper presents theo-retical contributions made in Spain related to designation of documen-tary types, series and units. The status of the issue presented here tries to delimitate the concept of “documentary typology”, essential for Ar-chival Science.

Conceptualising public-private partnerships: a critical appraisal of approaches to meanings and forms

Purpose – The purpose of this paper is to survey various meanings attached to a public-private partnership (PPP) and related aspects in Western literature, and identify commonalities and differences between them. Additionally, the article intends to critically assess conflicting and overlapping views on contractual and institutional PPPs, their forms and models, and draw insights for transitional economies. Design/methodology/approach – The article contrasts and compares views on PPP meanings, forms and models within Western PPP literature, and also draws comparisons with understanding of partnership aspects in the Russian language sources. The paper examines theories underpinning PPPs, builds connections to PPP advantages and drawbacks, and provides critical assessment of net benefits that PPPs may bring along to the society. Findings – The article concludes that future PPP research in transitional countries such as Kazakhstan and Russia, particularly in the area of organisational and power arrangements in partnerships, may delineate new concepts such as government as a guarantor of a PPP project, social significance of a PPP project, and risk management in a country’s contextual environment. Practical implications – In transitional countries, in which PPPs are in their infancy, clarification of theoretical positions, and identification of commonalities and differences between meanings attached to the PPP terminology may enable better decisions by researchers and practitioners in their selection and further development of partnerships and related concepts. Originality/value – Research in the field of PPPs in transitional countries such as Russia and Kazakhstan is in its infancy. The paper intends to contribute to the body of knowledge about PPPs by providing detailed account and categorisation of their principal meanings, forms, models, underpinning theories, and drawing insights for future research in transitional countries.

An appraisal of the implementation of freedom of association as a labour right: Nigerian perspective

No abstract available.

Program for the Spring 2016 MARAC Meeting: Archival Confluence: Connecting Theory and Practice

Conference Program

A critical appraisal of the social entrepreneurship paradigm in an international setting : a proposed conceptual framework

Communities in Collaboration: Building the Empire Archival Discovery Cooperative

Presentation from the MARAC conference in Pittsburgh, PA on April 14–16, 2016. S24; - Pittsburgh Pop-Up #2.

A Context For (Encoded Archival) Context: Let's Talk About CPF!

Presentation from the MARAC conference in Roanoke, VA on October 7–10, 2015. S17 - “Un session” II: A MARAC Mini Unconference.

Archival Collections and TMS at Reynolda House Museum of American Art

Presentation from the MARAC conference in Roanoke, VA on October 7–10, 2015. S8 - Minimal Processing and Preservation: Friends or Foes?

Predicting risk of violence through a self-appraisal questionnaire

The Self-Appraisal Questionnaire (SAQ) is a self-report that predicts the risk of violence and recidivism and provides relevant information about treatment needs for incarcerated populations. The objective of the present study was to evaluate the concurrent and predictive validity of this self-report in Spanish offenders. The SAQ was administered to 276 offenders recruited from several prisons in Madrid (Spain). SAQ total scores presented high levels of internal consistency (alpha = .92). Correlations of the instrument with violence risk instruments were statistically significant and showed a moderate magnitude, indicating a reasonable degree of concurrent validity. The ROC analysis carried out on the SAQ total score revealed an AUC of .80, showing acceptable accuracy discriminating between violent and nonviolent recidivist groups. It is concluded that the SAQ total score is a reliable and valid measure to estimate violence and recidivism risk in Spanish offenders.

Appraisal of open software for finite element simulation of 2D metal sheet laser cut.

FEA simulation of thermal metal cutting is central to interactive design and manufacturing. It is therefore relevant to assess the applicability of FEA open software to simulate 2D heat transfer in metal sheet laser cuts. Application of open source code (e.g. FreeFem++, FEniCS, MOOSE) makes possible additional scenarios (e.g. parallel, CUDA, etc.), with lower costs. However, a precise assessment is required on the scenarios in which open software can be a sound alternative to a commercial one. This article contributes in this regard, by presenting a comparison of the aforementioned freeware FEM software for the simulation of heat transfer in thin (i.e. 2D) sheets, subject to a gliding laser point source. We use the commercial ABAQUS software as the reference to compare such open software. A convective linear thin sheet heat transfer model, with and without material removal is used. This article does not intend a full design of computer experiments. Our partial assessment shows that the thin sheet approximation turns to be adequate in terms of the relative error for linear alumina sheets. Under mesh resolutions better than 10e−5 m , the open and reference software temperature differ in at most 1 % of the temperature prediction. Ongoing work includes adaptive re-meshing, nonlinearities, sheet stress analysis and Mach (also called ‘relativistic’) effects.

Forensic Injustice: Human Rights, Archival Science and Racialized Feminicide in Guatemala

The call to access and preserve the state records that document crimes committed by the state during Guatemala’s civil war has become an archival imperative entangled with neoliberal human rights discourses of “truth, justice, and memory.” 200,000 people were killed and disappeared in Guatemala’s civil war including acts of genocide in which 85% of massacres involved sexual violence committed against Mayan women. This dissertation argues that in an attempt to tell the official story of the civil war, American Human Rights organizations and academic institutions have constructed a normative identity whose humanity is attached to a scientific and evidentiary value as well as an archival status representing the materiality and institutionality of the record. Consequently, Human Rights discourses grounded in Western knowledges, in particular archival science and law, which prioritize the appearance of truth erase the material and epistemological experience of indigenous women during wartimes. As a result, the subjectivity that has surfaced on the record as most legible has mostly pertained to non-indigenous, middle class, urban, leftist men who were victims of enforced disappearance not genocide. This dissertation investigates this conflicting narrative that remembers a non-indigenous revolutionary masculine hero and grants him justice in human rights courtrooms simply because of a document attesting to his death. A main research question addressed in this project is why the promise of "truth and justice" under the name of human rights becomes a contentious site for gendered indigenous bodies? I conduct a discursive and rhetorical analysis of documentary film, declassified Guatemalan police and military records such as Operation Sofia, a military log known for “documenting the genocide” during rural counterinsurgencies executed by the military. I interrogate the ways in which racialized feminicides or the hyper-sexualized racial violence that has historically dehumanized indigenous women falls outside of discourses of vision constructed by Western positivist knowledges to reinscribe the ideal human right subject. I argue for alternative epistemological frames that recognize genocide as sexualized and gendered structures that have simultaneously produced racialized feminicides in order to disrupt the colonial structures of capitalism, patriarchy and heterosexuality. Ironically, these structures of power remain untouched by the dominant human rights discourse and its academic, NGO, and state collaborators that seek "truth and justice" in post-conflict Guatemala.

El uso de la documentación audiovisual en los programas informativos diarios de televisión

[SPA] El objetivo de la investigación es conocer cual es la aportación cuantitativa y cualitativa de la documentación audiovisual en la información que ofrece diariamente la televisión. El marco temporal de la investigación de campo se sitúa en los años 1993 y 1994, en un marco geográfico constituido por los canales que emiten en el estado español. El estudio parte de una aproximación teórica a la documentación periodística, a la documentación audiovisual y a los estudios sobre la comunicación de masas, y lleva a cabo una investigación de campo en tres áreas: 1) Análisis de programas informativos diarios de seis cadenas de televisión (ETB, TVE, Canal Sur, TV3, Antena 3 y Canal+), a través de tres muestras independientes. 2) Análisis de las peticiones de documentación audiovisual realizadas desde las redacciones de programas informativos a los servicios de documentación. 3) Estudio de las funciones, tareas, estructura y organización de los servicios de documentación de televisión, basado en encuestas, visitas y entrevistas. En anexo se ofrece el análisis detallado de 620 noticias, así como la información de los centros de documentación. La investigación concluye afirmando que la documentación audiovisual es uno de los elementos constitutivos de la información de actualidad, tanto por su presencia cuantitativa (más de un 40% de las noticias emitidas la emplean), como por su aportación cualitativa y su utilización generalizada en todas las secciones informativas. Las conclusiones señalan que la importancia de las noticias incide positivamente en el empleo de documentación audiovisual, sintetizan las funciones de esta documentación y las características específicas de su uso. Confirman el carácter de retroalimentación de la documentación informativa en televisión. Señalan un empleo de esta documentación como documentación puramente visual. Y afirman que la documentación audiovisual, además de contribuir en la producción, coadyuva a la calidad de los programas informativos, en la medida en que facilita la tarea de ofrecer una información más completa y contextualizada.

Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation: A Single Technology Appraisal. Evidence Review Group Report to NICE

1.1 Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors, including: congestive heart failure hypertension diabetes prior stroke or transient ischaemic attack age 75 years or older

A atividade fisica no processo de envelhecimento : uma proposta de trabalho

Universidade Estadual de Campinas . Faculdade de Educação Física