Suchergebnisse

Metadata only record ; This article is about the two-way causal relationships between the global food system and health and nutrition. It argues that the global food system begins and ends with health and that the prioritization and implementation of agricultural research and policy should consider health and nutrition effects. An integrated health and food policy approach is likely to be more effective in achieving both health and economic development goals that the current practice of separate sectoral policies. The article identifies a large number of health and nutrition factors affecting and affected by the food system and suggests research and policies to enhance positive effects and reduce negative ones. (CabDirect)

Extensions of the Cox proportional hazards model for survival data are studied where allowance is made for unobserved heterogeneity and for correlation between the life times of several individuals. The extended models are frailty models inspired by Yashin et al. (1995). Estimation is carried out using the EM algorithm. Inference is discussed and potential applications are outlined, in particular to statistical research in human genetics using twin data or adoption data, aimed at separating the effects of genetic and environmental factors on mortality.

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity asssessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details ‒ which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE‒MD project (Coordination of Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.