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      Environmental epidemiology and risk assessment: Exploring a path to increased confidence in public health decision-making

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          Abstract

          Throughout history, environmental epidemiology has proven crucial to identify certain threats to human health and to provide a basis for the development of life-saving public health policies. However, epidemiologists are facing challenges when studying tenuous threats such as environmental exposure to chemicals, whose association with adverse health effects may be difficult to characterize. As a result, epidemiological data can seldom be fully leveraged for quantitative risk assessment and decision-making. Despite two decades of efforts to improve a more systematic integration of human data to evaluate human health risks, assessors still heavily rely on animal data to do so, while epidemiology plays more of a secondary role. Although the need for more and better collaboration between risk assessors and epidemiologists is widely recognized, both fields tend to remain siloed. In 2017, the Health and Environmental Sciences Institute initiated a project engaging the epidemiology, exposure science, and regulatory communities with tripartite representation from regulators, industry, and academia in a dialogue on the use of environmental epidemiology for regulatory decision-making. Several focus groups attended by epidemiology, exposure science, and risk assessment experts were organized to explore incentives and barriers to collaboration, to ultimately bridge the gap between the various disciplines, and to realize the full potential of epidemiological data in risk assessment. Various ideas that have emerged from these meetings could help ensure the better integration of epidemiological data in quantitative risk assessment and contribute to building confidence in a robust and science-based regulatory decision-making process.

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          Most cited references12

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          Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

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            Mortality in relation to smoking: 50 years' observations on male British doctors.

            To compare the hazards of cigarette smoking in men who formed their habits at different periods, and the extent of the reduction in risk when cigarette smoking is stopped at different ages. Prospective study that has continued from 1951 to 2001. United Kingdom. 34 439 male British doctors. Information about their smoking habits was obtained in 1951, and periodically thereafter; cause specific mortality was monitored for 50 years. Overall mortality by smoking habit, considering separately men born in different periods. The excess mortality associated with smoking chiefly involved vascular, neoplastic, and respiratory diseases that can be caused by smoking. Men born in 1900-1930 who smoked only cigarettes and continued smoking died on average about 10 years younger than lifelong non-smokers. Cessation at age 60, 50, 40, or 30 years gained, respectively, about 3, 6, 9, or 10 years of life expectancy. The excess mortality associated with cigarette smoking was less for men born in the 19th century and was greatest for men born in the 1920s. The cigarette smoker versus non-smoker probabilities of dying in middle age (35-69) were 42% nu 24% (a twofold death rate ratio) for those born in 1900-1909, but were 43% nu 15% (a threefold death rate ratio) for those born in the 1920s. At older ages, the cigarette smoker versus non-smoker probabilities of surviving from age 70 to 90 were 10% nu 12% at the death rates of the 1950s (that is, among men born around the 1870s) but were 7% nu 33% (again a threefold death rate ratio) at the death rates of the 1990s (that is, among men born around the 1910s). A substantial progressive decrease in the mortality rates among non-smokers over the past half century (due to prevention and improved treatment of disease) has been wholly outweighed, among cigarette smokers, by a progressive increase in the smoker nu non-smoker death rate ratio due to earlier and more intensive use of cigarettes. Among the men born around 1920, prolonged cigarette smoking from early adult life tripled age specific mortality rates, but cessation at age 50 halved the hazard, and cessation at age 30 avoided almost all of it.
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              Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework.

              Maintaining research and development (R&D) productivity at a sustainable level is one of the main challenges currently facing the pharmaceutical industry. In this article, we discuss the results of a comprehensive longitudinal review of AstraZeneca's small-molecule drug projects from 2005 to 2010. The analysis allowed us to establish a framework based on the five most important technical determinants of project success and pipeline quality, which we describe as the five 'R's: the right target, the right patient, the right tissue, the right safety and the right commercial potential. A sixth factor - the right culture - is also crucial in encouraging effective decision-making based on these technical determinants. AstraZeneca is currently applying this framework to guide its R&D teams, and although it is too early to demonstrate whether this has improved the company's R&D productivity, we present our data and analysis here in the hope that it may assist the industry overall in addressing this key challenge.
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                Author and article information

                Contributors
                Journal
                Glob Epidemiol
                Glob Epidemiol
                Global Epidemiology
                Elsevier
                2590-1133
                08 January 2021
                November 2021
                08 January 2021
                : 3
                : 100048
                Affiliations
                [a ]Health and Environmental Sciences Institute, Washington, DC, United States of America
                [b ]U.S. Environmental Protection Agency, Washington, DC, United States of America
                [c ]ExxonMobil Biomedical Sciences, Inc., Annandale, NJ, United States of America
                [d ]Center for Health Sciences, Exponent, Inc., Menlo Park, CA, United States of America
                [e ]Oregon Health Authority, Portland, OR, United States of America
                [f ]Health & Medical, Chevron Services Company (a division of Chevron USA Inc.), Houston, TX, United States of America
                Author notes
                [* ]Corresponding author at: Health and Environmental Sciences Institute, 740 15th Street, 6th Floor, Washington, DC 20005, United States of America. sdeglin@ 123456hesiglobal.org
                Article
                S2590-1133(21)00001-8 100048
                10.1016/j.gloepi.2021.100048
                10445995
                37635726
                7256e625-a999-482c-87ae-728b2ca342bf
                © 2021 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 30 July 2020
                : 16 November 2020
                : 16 November 2020
                Categories
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                environmental epidemiology,risk assessment,public health,decision-making

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