248,677 research outputs found
“Progression-free survival as an end-point in clinical trials of biotherapeutic agents”
No full textProgression-free survival (PFS), the time from registration or randomisation of a patient
until objective disease progression or death, can be considered as an outcome for clinical
research and also as a basis for regulatory approval. Current experience suggests that
greater standardisation and consistency are needed for clinical trials utilising PFS endpoints.
To this end, the Biotherapy Development Association (BDA) convened a breakout
session on the topic of PFS during its Third Alpine Meeting held 14–16 March 2007. Representatives
of the pharmaceutical industry, regulatory agencies, academia, and patient
advocacy groups identified challenges, developed recommendations, and worked to build
consensus regarding the conduct of clinical trials utilising PFS as an end-point to help
speed new targeted biologics to the patient bedside
Microenterprise Development Review: Volume 7 : No. 2 : December, 2004
No full textThe first article of this issue of Microenterprise Development Review discusses activity based costing (ABC) systems. Activity-based costing (ABC) inserts an additional, intermediate step in the traditional costing process by first assigning the costs (direct and indirect) to various activities, which are then allocated to the individual products and branches. The author argues that when properly designed, an ABC system can highlight a wide range of issues within a microfinance institution. The second article explores the alternative ways small and medium sized enterprises finance themselves in Latin America. This article includes case studies from across the region as well as recommendations
Microenterprise Development Review: Volume 2 : No. 2 : January, 2000
No full textThe first article of this issue of the Microenterprise Development Review highlights four key issues that credit unions in Latin America must grapple with today to become effective financial institutions: rehabilitation, supervision, governance, and consolidation. The second article discusses the lack of reliable information about borrower credit in the region and the methods employed by financial institutions to offset risk. The author argues that credit bureaus can solve this problem by providing the necessary information to evaluate a borrower\u27s ability and willingness to repay their debts
Biotherapy of Cancer: Break the Barriers to Foster Translation oF knowledge
No full text Biotherapy of cancer holds great promise for its potential to lead to the identification of novel, selective, and effective treatments against cancer. However, the clinical development of biopharmaceuticals and biotherapy products is hampered by several and diverse barriers. Herein, we will address some of the critical issues identified both at the national and European level as the major obstacles for the translation of knowledge into clinical applications in the field of biotherapy and immunotherapy of cancer. We will also illustrate specific initiatives undertaken both in Europe and in Italy in order to support the translational and clinical research and that are expected to have a favorable impact on the process of clinical development of novel and more effective therapeutic interventions against cancer. The contents of this article are directly referred to the event “International Clinical Trials’ Day on Biotherapy of Cancer” organized in the context of the OECI Genoa 2008, with the sponsorship of Alliance Against Cancer (ACC) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health), and under the auspices of the European Clinical Research Infrastructures Network (ECRIN). This event sees the active participation of representatives of the ISS and of the Italian Network for Tumor Biotherapy, both involved in a project recently funded by ACC and aimed at the promotion of clinical research in the field of cancer biotherapy and immunotherapy, through the creation of a national network of clinical cancer research centers and GMP facilities dedicated to the production of biological drugs and advanced medicinal products. </jats:p
Anthropometric Failures: Nutrition, Early Child Interventions and Emotional, and Cognitive Development Potentials
No full textThis presentation deals with the following issue: how poverty, poor health, nutrition and care affect child development. The author reviews a series of "capabilities approaches," including concepts such as the conversion of primary good into the person\u27s ability to promote his/her ends. This presentation was discussed at the IDB-PAHO Workshop, Washington DC, 25th of May 2007
The Institutional Environment of Megaproject Planning and Appraisal
No full textThis paper compares the contributions of three different approaches to the analysis of the institutional environment of transport policy development and megaproject planning and appraisal: the sociological approach to institutions; the political new institutionalism; and new institutional economics. It shows that institutions have been usually understood in different ways by these fields, emphasizing different elements of this relevant subject. It is here recommended to follow Scott (2012) who claims that while one approach may be more suited to study a particular dimension, others may be better suited to study other dimensions. This author claims that there are three pillars of institutions: cultural-cognitive elements, normative elements and regulative elements. They are linked to the abovementioned approaches. The cultural-cognitive element is related to symbols (including words, signs, and gestures), which shape the meaning of objects and activities, the normative element is associated with rules that introduce a prescriptive, evaluative and obligatory dimension into social life, and the regulative elements refer to rule-setting, monitoring and sanctioning activities. his paper shows that the key to understand the challenge of analyzing the institutional environment of megaproject planning and appraisal is to be aware of the different institutional elements in place, and to use the most suited approach to analyze each one of them. Moreover, it also illustrates that there are no “pure cases” where only one element is responsible for the outcomes, and depending on the pillar under analysis, one of the abovementioned approaches to institutions may be more suited as a conceptual framework to thoroughly analyze the problem
Equalizing Opportunities for Human Development (in One Country)
No full textThis study develops a framework to investigate the optimal allocation of a country\u27s fiscal resources to help equalize opportunities for human development. The author argues that the proper role for policy is the pursuit of equality of opportunities as opposed to equality of outcomes. Because outcomes reflect the combination of a person\u27s socioeconomic background and effort, the role of public policy is then to equate results conditional on effort. A stylized model formalizes this argument and provides insights on policy rules to equalize opportunities within a one country framework. The paper provides interesting reflections on political economy issues and suggests extending the framework to provide guidance to development institutions on the optimal allocation of lending resources across member countries with different socioeconomic conditions as to equate their opportunities
The Development of Sculpture in the Quito School
No full textMagdalena Gallegos de Donoso, Ecuadorian anthropologist and art historian, author of over fifty exhibition catalogues, Director of the Central Bank of Ecuador Museums
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Expanding APHONs Pediatric Chemotherapy/Biotherapy Provider and Instructor Program to Spanish-Speaking Countries: Pilot Series Development and Evaluation.
No full textBackground: To address the need for standardized, comprehensive chemotherapy/biotherapy education in Latin American and Caribbean (LAC) countries, the Association of Pediatric Hematology/Oncology Nurses (APHON) Pediatric Chemotherapy/Biotherapy Provider and Instructor program courses were culturally adapted, translated to Spanish, and piloted. The process of course adaptation and implementation are described. A Context, Input, Process, Product model outcomes evaluation determined: (a) differences in pass rates by test version and pilot location, (b) predictors of pass rates, (c) course appropriateness for nurses education and practice levels, and (d) strategies for course improvements. Methods: The Spanish APHON Pediatric Chemotherapy/Biotherapy Provider program was piloted four times and the Instructor program twice with nurses from Mexico, Central America, the Caribbean, South America, and Spain. Statistical analysis identified factors associated with pass rates. Results: Of the 203 students in four Spanish APHON Provider program courses, data from 108 students (three pilots) were analyzed (one unplanned pilot excluded for missing data). Significant predictors of pass rates included: pediatric oncology frontline nurses (OR = 9.86; 95% CI [2.56, 65.23]; p = .004), nurses dedicated to an inpatient or outpatient unit (non-rotating) (OR = 6.79 [1.29, 51.98]; p = .033), and graduation from a 5-year nursing program (OR = 5.92; 95% CI [1.30, 33.15]; p = .028). Discussion: The Spanish APHON Pediatric Chemotherapy/Biotherapy program was determined appropriate for nurses education and practice levels in LAC countries. Through the APHON Spanish language instructor network, pediatric oncology nurses in LAC countries have increased access to standardized, comprehensive chemotherapy/biotherapy education
Real Estate Development: An overview
No full textGreen Open Access added to TU Delft Institutional Repository 'You share, we take care!' - Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public.Urban Development Managemen
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