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 Aquatic Oligochaeta (Annelida, Clitellata) of the Great Smoky Mountains National Park, North Carolina and Tennessee, USA

ID: 8987; Annual Project Report for 2003, Project No. DLIA 2003-14 issued August 17, 2004

Phobos: The design and implementation of embedded software for a low cost radar warning receiver

This portfolio thesis describes work undertaken by the author under the Engineering Doctorate program of the Institute for System Level Integration. It was carried out in conjunction with the sponsor company Teledyne Defence Limited. A radar warning receiver is a device used to detect and identify the emissions of radars. They were originally developed during the Second World War and are found today on a variety of military platforms as part of the platform’s defensive systems. Teledyne Defence has designed and built components and electronic subsystems for the defence industry since the 1970s. This thesis documents part of the work carried out to create Phobos, Teledyne Defence’s first complete radar warning receiver. Phobos was designed to be the first low cost radar warning receiver. This was made possible by the reuse of existing Teledyne Defence products, commercial off the shelf hardware and advanced UK government algorithms. The challenges of this integration are described and discussed, with detail given of the software architecture and the development of the embedded application. Performance of the embedded system as a whole is described and qualified within the context of a low cost system.

Public firm sponsorship of open source software: A knowledge-based approach to open innovation

As an emerging innovation paradigm gaining momentum in recent years, the open innovation paradigm is calling for greater theoretical depth and more empirical research. This dissertation proposes that open innovation in the context of open source software sponsorship may be viewed as knowledge strategies of the firm. Hence, this dissertation examines the performance determinants of open innovation through the lens of knowledge-based perspectives. Using event study and regression methodologies, this dissertation found that these open source software sponsorship events can indeed boost the stock market performance of US public firms. In addition, both the knowledge capabilities of the firms and the knowledge profiles of the open source projects they sponsor matter for performance. In terms of firm knowledge capabilities, internet service firms perform better than other firms owing to their advantageous complementary capabilities. Also, strong knowledge exploitation capabilities of the firm are positively associated with performance. In terms of the knowledge profile of sponsored projects, platform projects perform better than component projects. Also, community-originated projects outperform firm-originated projects. Finally, based on these findings, this dissertation discussed the important theoretical implications for the strategic tradeoff between knowledge protection and sharing.

La actividad laboral de las familias africanas y latinoamericanas reagrupadas en la España mediterránea

La investigación se basa en los resultados de una encuesta realizada en 2009-2010, por el equipo investigador, a 348 inmigrados reagrupantes africanos y a 457 latinoamericanos que residen en las provincias litorales entre Girona y Almería. La información que se ofrece está referida a los aspectos laborales de estos dos colectivos continentales, tanto a escala del conjunto territorial indicado como para tres subáreas incluidas en él: Cataluña litoral, Comunidad Valenciana y Murcia-Almería; según los temas, se trata por separado a los reagrupantes y a los subgrupos familiares que conviven en España (reagrupantes, cónyuges, hijos). El estudio se centra en las estructuras de empleo por sectores económicos. También se estudian las redes migratorias, tan decisivas en la orientación de estos flujos hacia España, la regulación laboral de estos trabajadores, la repercusión de la crisis actual en los empleos de las familias reagrupadas (paro, número de ocupados por familia e ingresos), la satisfacción laboral de los miembros de las familias (horas de trabajo, problemas laborales y salariales) y la estabilidad laboral (antigüedad en el empleo, cursos de formación profesional, trabajo actual y expectativas del inmigrante). El recorrido por los temas laborales indicados, vinculados a los distintos grupos continentales y familiares y a las diferentes escalas territoriales, concluyen en mostrar situaciones económicas y sociales muy diferentes entre africanos y latinoamericanos, y entre los que residen en Cataluña litoral y en Murcia-Almería, en lo que intervienen, entre otras causas, los distintos «capitales» personales aportados por los dos colectivos continentales para acceder al empleo (formación, idioma, …) y las diferentes estructuras económicas de los territorios estudiados. Los africanos y los que residen en las provincias meridionales son los que presentan peores situaciones socioeconómicas.

Patrocínio no circuito nacional de surf : estudo da notoriedade, atitude e intenção de compra dos espectadores face a uma marca

Com a realização deste estudo pretendeu-se cumprir dois objetivos: i) aferir a eficácia do patrocínio desportivo através da utilização de medidas como a notoriedade da marca, a atitude face ao patrocinador e a intenção de compra dos espectadores presentes no circuito nacional de surf (Liga Moche); ii) analisar a forma como o envolvimento das pessoas com o surf pode ter influência na eficácia do patrocínio. Para cumprir estes objetivos foram aplicados 250 questionários a espectadores presentes nas provas do circuito nacional de surf. Os dados foram analisados através de estatística descritiva, testes de correlação de Pearson e de tstudent. Os resultados indicam que a marca patrocinadora do evento de surf, a Moche, apresenta elevados níveis de notoriedade espontânea (83,2%) e assistida (91,2%) entre os espectadores do circuito nacional e que os espectadores apresentam também atitudes favoráveis assim como intenções de compra favoráveis. Verificou-se também uma correlação significativamente positiva entre a atitude face ao patrocinador e as intenções de compra. Por último, os praticantes de surf e os espectadores dos eventos apresentam uma atitude mais favorável e maiores intenções de compra dos produtos patrocinadores do que os que não praticam surf nem costumam assistir a eventos de surf. Estes resultados devem ser levados em consideração pelos responsáveis de futuros eventos de surf.

The decline of ameriquest : a case study

In the subprime lending market, Ameriquest Mortgage Company is one of the leading lenders. It is widely known for its advertising slogan of “proud sponsor of the American dream.” Yet in 2006, an investigation into unlawful mortgage lending practices and the subsequent $325 million multi-State settlement brought even more attention to this company. What caused this lawsuit which brought irreparable damage to its reputation and financial loss for Ameriquest? This study focuses on the Information System Security management of the company. The study first introduces Ameriquest, and then briefly describes the lawsuit and settlement, and then discusses the IS security control in Ameriquest. The discussion will cover the internal control, external control, and technical controls of the company.