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Scientific Concept of the National Cohort (status ... - Nationale Kohorte

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A.1<br />

A.1 Introduction and overview<br />

Time schedule:<br />

� The preparatory phase is ongoing, which includes planning, <strong>the</strong> feasibility study, and<br />

<strong>the</strong> pilot study (see figure 1.3).<br />

� This application refers to <strong>the</strong> period <strong>of</strong> 10 years from mid-2012 to mid-2022 (Recruitment,<br />

reexamination, and active follow-up).<br />

� Thereafter, we anticipate a period <strong>of</strong> up to 20 years in which data and biosamples will<br />

be made available for research projects.<br />

� Research is possible after recruitment/baseline assessment is finished (except smaller<br />

methodological studies which may start earlier). However, research on <strong>the</strong> cohortrelated<br />

questions will be possible only after <strong>the</strong> reassessment and <strong>the</strong> first active<br />

follow-ups are finished.<br />

Funding:<br />

� Funding for <strong>the</strong> preparatory phase is covered by Helmholtz association and BMBF.<br />

� For <strong>the</strong> current application funding <strong>of</strong> 210 million Euros is needed for 10 years (for<br />

details see Sect. B.6).<br />

� For follow-up <strong>of</strong> study participants and for <strong>the</strong> supply <strong>of</strong> data and biosamples after<br />

2022, additional funding <strong>of</strong> approx. 5 million Euros per year is needed (for details see<br />

Sect. B.6).<br />

� Funding <strong>of</strong> research: The <strong>National</strong> <strong>Cohort</strong> is a resource for epidemiologic and clinical<br />

research. This means that for research projects based on this resource separate<br />

funding must be found. Here, <strong>the</strong> state and governmental funding <strong>of</strong> universities and<br />

Helmholtz Centers and standard funding organizations such as <strong>the</strong> Deutsche Forschungsgemeinschaft<br />

(DFG), Federal Ministry <strong>of</strong> Research (BMBF), Federal Ministry<br />

<strong>of</strong> Health (BMG), <strong>the</strong> Federal States within Germany, and international funders such<br />

as <strong>the</strong> European Union (EU), US <strong>National</strong> Institutes <strong>of</strong> Health (NIH), etc, and industry<br />

shall be mentioned. Experience with existing cohorts shows that <strong>the</strong>re are realistic<br />

opportunities to receive funding from <strong>the</strong>se organizations for research as soon as <strong>the</strong><br />

<strong>National</strong> <strong>Cohort</strong> is established.<br />

A.1.4 <strong>Scientific</strong> aims <strong>of</strong> <strong>the</strong> <strong>National</strong> <strong>Cohort</strong><br />

The <strong>National</strong> <strong>Cohort</strong> is designed to address research questions concerning a wide range <strong>of</strong><br />

possible causes <strong>of</strong> major chronic diseases. To this end, <strong>the</strong> collection <strong>of</strong> biomaterials in combination<br />

with extensive information from questionnaires and medical examinations represents<br />

one <strong>of</strong> <strong>the</strong> central components. Biomarker measurements will cover domains as diverse as<br />

nutrition and metabolism, hormonal and o<strong>the</strong>r physiological effects <strong>of</strong> chronic psychological<br />

stress, viral and bacterial infections, immune <strong>status</strong>, and genetics and epigenetics.<br />

The objectives spanning <strong>the</strong> studies to be conducted within <strong>the</strong> <strong>National</strong> <strong>Cohort</strong> will provide<br />

a sound basis for establishing improved and more targeted measures for <strong>the</strong> primary and<br />

secondary prevention <strong>of</strong> major diseases, tailored to <strong>the</strong> German population. In <strong>the</strong> following,<br />

we define general objectives <strong>of</strong> <strong>the</strong> <strong>National</strong> <strong>Cohort</strong>, and within <strong>the</strong>ir general scope we<br />

emphasize more specific areas <strong>of</strong> research that will be <strong>of</strong> particular focus.<br />

General objective 1: Identification <strong>of</strong> etiological pathways from lifestyle and environmental<br />

risk factors to major chronic diseases and functional impairments.<br />

Within <strong>the</strong> scope <strong>of</strong> this first general objective, one set <strong>of</strong> more specific aims is to increase<br />

understanding <strong>of</strong> <strong>the</strong> role <strong>of</strong> particular risk factors in <strong>the</strong> development <strong>of</strong> <strong>the</strong> following major<br />

forms <strong>of</strong> chronic diseases:<br />

6

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