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An increase in the number of identified therapeutic cancer targets achieved through recent biomedical research has resulted in the generation of a large number of molecules that need to be tested further. Current development of (anticancer) drugs is a rather inefficient process that for an average new molecule takes around 10–15 years. It is also a challenging process as it is associated with high costs and a low rate of approval. It is known that less than 10% of new molecular entities entering clinical Phase I testing progress beyond the investigational programme and reach the market; this probability is even lower for anticancer agents. In 2003, the US Food and Drug Administration (US FDA) declared the urgent need for new toolkits to improve the critical development path that leads from scientific discovery to the patient. In this scenario, Phase 0 (zero) trials should allow an early evaluation in humans of pharmacokinetic and pharmacodynamic profiles of test compounds through administration of sub-pharmacological doses and for a short time period to a low number of humans. Typically, Phase 0 studies have no therapeutic or diagnostic intent. Owing to the low doses administered and the low risk of toxicity, shorter preclinical packages to support these studies are required. Phase 0 trials have been proposed to help in making an early selection of promising candidates for further evaluation in Phase I–III trials, providing a potentially useful instrument for drug discovery, particularly in the field of oncology. Phase 0 studies are expected to reduce costs of drug development, and to limit the preclinical in vitro and in vivo testing and the time period of drug development. However, there are also concerns about the utility and feasibility of Phase 0 studies. In January 2006, guidelines on exploratory investigational new drug studies in humans have been published by the US FDA, and currently a Phase 0 programme is ongoing at the National Cancer Institute to evaluate the impact (feasibility and utility) of Phase 0 studies on drug development. In Europe, a Position Paper produced by the Evaluation of Medicinal Products (EMEA) in 2004 raised the possibility of a reduced preclinical safety package to support early microdose clinical studies, and, as announced by a recent Concept Paper on medicinal products published by the committee for medicinal products for human use of the EMEA, EMEA's guidelines on Phase 0 studies are expected shortly. The true impact of Phase 0 studies on the drug development process as well as on the safety needs to be carefully explored.British Journal of Cancer (2007) 97, 577–581. doi:10.1038/sj.bjc.6603925 www.bjcancer.com Published online 28 August 2007 [ABSTRACT FROM AUTHOR]

Following the report of the Stiglitz Commission, measuring and comparing well-being across countries has gained renewed interest. Yet, analyses that go beyond income and incorporate non-market dimensions of welfare most often rely on the assumption of identical preferences to avoid the difficulties related to interpersonal comparisons. In this paper, we suggest an international comparison based on individual welfare rankings that fully retain preference heterogeneity. Focusing on the consumption-leisure trade-off, we estimate discrete choice labor supply models using harmonized microdata for 11 European countries and the US. We retrieve preference heterogeneity within and across countries and analyze several welfare criteria which take into account that differences in income are partly due to differences in tastes. The resulting welfare rankings clearly depend on the normative treatment of preference heterogeneity with alternative metrics. We show that these differences can indeed be explained by estimated preference heterogeneity across countries-rather than demographic composition. [ABSTRACT FROM AUTHOR]

This paper discusses partial results of an ongoing project focused on analysing the current usefulness and implications of developing research on agent-based social simulation models beyond academic, hobbyist or educational purposes. Design, development and testing phases of such modelling are discussed along with common issues evidence-driven modellers often face whilst collecting, analysing and modelling quantitative and qualitative data into social simulations. It also includes a discussion on the evidence gathered in published literature and structured interviews with researchers that have lead mid- to long-term (3-5 years) projects on social simulation in Europe and the United States. Finally, good-practice recommendations are put forward by presenting a development methodology fully guided by evidence. [ABSTRACT FROM AUTHOR]

The paper focuses on the fundamental debate that is going on in Europe and the United States about whether genes and genetic diagnostic methods are to be regarded as inventions or subject matter eligible for patent protection, or whether they are discoveries or principles of nature and thus excluded from patentability. The study further explores some possible scenarios of American influences on European patent applications with respect to genetic diagnostic methods. Our analysis points out that patent eligibility for genes and genetic diagnostic methods, as discussed in the United States in the Association of Molecular Pathology versus US Patent and Trademark Office decision, is based on a different reasoning compared with the European Patent Convention. [ABSTRACT FROM AUTHOR]

Over the past few decades, a variety of groups have begun to argue that the US and European patent systems do not adequately represent the public interest in their decision making and that they need to undergo fundamental changes to their structure and orientation. These challengers have adopted similar strategies-in terms of the venues chosen and the arguments, evidence, and rhetoric used-in each context. However, they have experienced more success in Europe than in the United States. This paper begins to explain this difference by arguing that the US and European patent policy domains have different 'expertise barriers'-formal and informal rules that make it difficult for those without the knowledge that is recognized as relevant and legitimate in that domain to engage as equals. [ABSTRACT FROM AUTHOR]

The objective of this study was to assess the level of awareness of prostate cancer (PCa) among the general public and PCa patients in Europe and North America. A survey was undertaken across four European countries (UK, Germany, Italy and Spain), and across the United States and Canada in late 2007. In total, 1008 men with PCa and their partners (the ‘prostate sample’), and 911 men without PCa and their partners (the ‘well sample’) participated in the survey, all aged 50 years. Interviews were conducted through telephone, pen and paper, and online. Many people surveyed (53%) thought that breast cancer is more common than PCa. Moreover, 1 in 10 people from the well sample (10%) thought that PCa affects both men and women. When the prostate sample was asked about their perceived level of risk of PCa before diagnosis, 50% believed that they/their husband or partner were previously at low or very low risk, before they were diagnosed. Awareness of the major risk factors for PCa (age and family history) was generally good, but respondents were less clear about the role of other potential factors, such as smoking and drinking alcohol. This international survey, thought to be largest of its type, shows that although patient and public awareness of PCa is generally satisfactory, there is still a considerable lack of clarity about PCa risk factors, and a danger for people to underestimate their own/their partner's perceived risk for PCa. Programmes to responsibly educate and inform men and their partners about risk factors, prevalence and screening tools for PCa are required. [ABSTRACT FROM AUTHOR]

This paper focuses on the issue of separate schooling. Diverse societies use schools to develop shared value systems, strengthen democratic engagements and provide better educational outcomes. However, in Europe, the United States, Australia and elsewhere groups of parents and communities have been invoking human rights claims to challenge the state, often successfully, to demand separate schools for their children or the right to send their children to a school of their choosing, irrespective of the consequences for society at large. Yet do such separate schools reflect an increased respect for the rights of minorities and a commitment to help them reach their full potential? Do they help remove marginalization and can they ever lead to the establishment of stable and peaceable communities? Or do they undermine societal commitments to intergroup harmony and perpetuate stereotypes, racism and ethnocentric thinking? Do they keep existing inequalities in place and deny young people the opportunities they need to become full-fledged members of society? It is argued here that regardless of location, separate schools are part of the problem, not the solution. [ABSTRACT FROM AUTHOR]

The article cites a U.S. report that states that Asian nations are catching up with Europe and the United States in terms of scientific output. According to the report, in 2004, countries from the Asia Pacific region including China, South Korea, Taiwan, Japan, Singapore and India produced 25 percent of the world's research papers. By comparison, Europe produced 38 percent of the world's scientific papers, and the United States produced 33 percent. Within Asia, China, South Korea, Singapore and Taiwan grew the most. In China, some institutions even pay researchers extra for publications in indexed journals, especially ones that carry widely cited articles.