Protecting Natura 2000: Avoiding Adverse Impact on European Sites

Case C-258/11 Peter Sweetman, Ireland, Attorney General, Minister for the Environment, Heritage and Local Government v An Bord Pleanála
(Not yet reported)

The European Union funded NEOShield project: A global approach to near-Earth object impact threat mitigation

Although discussions are underway within the Action Team 14 of the United Nations COPUOS, there is currently no concerted international plan addressing the impact threat from near-Earth objects (NEOs) and how to organize, prepare and implement mitigation measures. We report on a new international project to address impact hazard mitigation issues, being the subject of a proposal submitted to the European Commission in response to the 2011 FP7 Call "Prevention of impacts from near-Earth objects on our planet". Our consortium consists of 13 research institutes, universities, and industrial partners from 6 countries and includes leading US and Russian space organizations. The primary aim of the project, NEOShield, is to investigate in detail the three most promising mitigation techniques: the kinetic impactor, blast deflection,and the gravity tractor, and devise feasible demonstration missions. Furthermore, we will investigate options for an international strategy for implementation when an actual impact threat arises. The NEOShield project was formally accepted by the European Commission on 17 November 2011 and funded with a total of 5.8 million Euros for a period of 3.5 years. The kick-off meeting took place at the DLR Institute of Planetary Research, Berlin, in January 2012. In this paper we present a brief overview of the planned scope of the project.

NEOShield: An European Project to Address Impact Hazard Mitigation Issues

The European Union NEOShield project is desribed.The primary aim of the project is to investigate in detail the three most promising mitigation techniques: the kinetic impactor, blast deflection, and the gravity tractor, and devise feasible demonstration missions.

Cystic Fibrosis Foundation and European Cystic Fibrosis Society Survey of cystic fibrosis mental health care delivery

Background: Psychological morbidity in individuals with cystic fibrosis (CF) and their caregivers is common. The Cystic Fibrosis Foundation (CFF) and European Cystic Fibrosis Society (ECFS) Guidelines Committee on Mental Health sought the views of CF health care professionals concerning mental health care delivery. Methods: An online survey which focused on the current provision and barriers to mental health care was distributed to CF health care professionals. Results: Of the 1454 respondents, many did not have a colleague trained in mental health issues and 20% had no one on their team whose primary role was focused on assessing or treating these issues. Insufficient resources and a lack of competency were reported in relation to mental health referrals. Seventy-three percent of respondents had no experience with mental health screening. Of those who did, they utilized 48 different, validated scales. Conclusions: These data have informed the decision-making, dissemination and implementation strategies of the Mental Health Guidelines Committee sponsored by the CFF and ECFS.

European Cystic Fibrosis Society Standards of Care: Quality Management in cystic fibrosis

Since the earliest days of cystic fibrosis (CF) treatment, patient data have been recorded and reviewed in order to identify the factors that lead to more favourable outcomes. Large data repositories, such as the US Cystic Fibrosis Registry, which was established in the 1960s, enabled successful treatments and patient outcomes to be recognized and improvement programmes to be implemented in specialist CF centres. Over the past decades, the greater volumes of data becoming available through Centre databases and patient registries led to the possibility of making comparisons between different therapies, approaches to care and indeed data recording. The quality of care for individuals with CF has become a focus at several levels: patient, centre, regional, national and international. This paper reviews the quality management and improvement issues at each of these levels with particular reference to indicators of health, the role of CF Centres, regional networks, national health policy, and international data registration and comparisons. 

Dose-response relationship in phase 1 clinical trials: a European Drug Development Network (EDDN) Collaboration Study

Introduction: Because a dose–response relationship is characteristic of conventional chemotherapy, this concept is widely used for the development of novel cytotoxic (CTX) drugs. However, the need to reach the MTD to obtain optimal benefit with molecularly targeted agents (MTA) is controversial. In this study, we evaluated the relationship between dose and efficacy in a large cohort of phase I patients with solid tumors.

Experimental Design: We collected data on 1,182 consecutive patients treated in phase I trials in 14 European institutions in 2005–2007. Inclusion criteria were: (i) patients treated within completed single-agent studies in which a maximum-administered dose was defined and (ii) RECIST/survival data available.

Results: Seventy-two percent of patients were included in trials with MTA (N = 854) and 28% in trials with CTX (N = 328). The objective response (OR) rate was 3% and disease control at 6 months was 11%. OR for CTX was associated with higher doses (median 92% of MTD); this was not the case for MTA, where patients achieving OR received a median of 50% of MTD. For trials with MTA, patients treated at intermediate doses (40%–80%) had better survival compared with those receiving low or high doses (P = 0.038). On the contrary, there was a direct association between higher dose and better OS for CTX agents (P = 0.003).

Conclusion: Although these results support the development of novel CTX based on MTD, we found no direct relationship between higher doses and response with MTA in unselected patients. However, the longest OS was seen in patients treated with MTA at intermediate doses (40%–80% of MTD)