Suchergebnisse

Radon gas is a pulmonary carcinogen and the second leading cause of lung cancer after smoking. There are many countries that have not implemented measures to reduce the risk it poses to the general population. The aim of this study was to locate available evidence on exposure to residential radon and the regulations to monitor and control this across Central and South America, by conducting a review of the scientific literature and government documents in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. This review included 31 studies which had taken measurements of radon in these countries. While Brazil, Argentina, and Peru have undertaken most research, no country in Central and South America has a national map of exposure to residential radon. The prevalence of exposure to radon was uneven, both among the different countries and within individual countries. No country has regulations to prevent the entry of radon into homes, and nine countries have not set maximum permissible concentrations for residential radon. There is a limited number of studies in South and Central America, with a limited spatial coverage, and there is a need to improve knowledge on exposure to residential radon and its effects, and for governments to take the necessary actions to introduce preventive measures in their statutory regulations.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision‐making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.