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

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A.1 A.1 Introduction and overview their clinical consequences (n=30,000, 30–80 years). This Neuro Cohort Bonn and the National Cohort will be complementary both in design and concerning their scientific questions. To facilitate future collaboration, Bonn aims to harmonize the data standards and standard operating procedures (SOP) with those of the National Cohort and other national and international ongoing cohort studies. Future data and biosamples of the Neuro Cohort will be made available for collaborative research. The DZNE was recently established in the Helmholtz Association with population research into neurodegenerative diseases as one of its core tasks. In this regard, the Neuro Cohort Bonn and the National Cohort are independent but closely interacting partners who will form a strategic alliance for population research in Germany. � German Environmental Health Birth Cohort: A birth/pregnancy cohort of up to 200,000 newborns is currently planned on behalf of the Federal Environmental Agencey (Umweltbundesamt, UBA). One attractive approach under discussion is to use participants of the National Cohort at reproductive age to recruit mothers during pregnancy and to include their newborns into the birth cohort. This recruitment could take place continuously during the 10-year fieldwork period of the National Cohort. The numbers of recruited pregnant women/newborns could be increased by using the infrastructure of the National Cohort to draw a larger random sample in the appropriate age range. Furthermore, it would widen the scope from pregnancy/birth to women who want to become pregnant. In 2009 a planning project was contracted by the UBA. The final report is presently being prepared. � LIFE study in Leipzig: Objective of LIFE is the investigation of molecular causes of life style and environment associated diseases to develop new processes, products and services for diagnostics and prevention of common life style diseases. LIFE includes population-based studies in adults (n=10,000, 40–80 years) and children (n=5,000, 0-18 years) as well as seven patient cohorts (total n=17,000). The adult cohort is being established in close interaction with the National Cohort. � Clinical research group Goettingen: At Goettingen university, a prospective cohort will be established, based on a DFG-funded clinical research group. It includes a population cohort using the baseline protcol of the National Cohort (n=3,000, 20-69 years), and a patient cohort (n=3,000, psychotic patients, 20-69 years). � Patient cohorts of German Centers for Health Research: German Centers for Health Research are being established for lung research, cardiovascular research, translational cancer research, and infectious disease research and have already been implemented for diabetes research and neurodegenerative disorders (see above). Important synergism between the National Cohort and the German Centers (i) should improve our understanding of early development of the diseases of interest, and (ii) the National Cohort can be used as a control cohort for patient cohorts which are being established. International collaborations and coordination: � Large European Cohorts: As mentioned above in Sect. A.1.5 and described in detail in Sect. A.3.9, compatibility of questionnaires, medical examinations and other study elements of the National Cohort (n=200,000, 20–69 years), with other large European Cohorts is planned, especially with UK Biobank (n=500,000, 40–69 years), the Swedish LifeGene study (n=500,000, 0–45 years), and the French CONSTANCES study (n=200,000, 18–69 years). � The National Cohort as blueprint for satellite cohort studies in neighbouring German speaking regions: for example, regions of Northern Italy (South Tyrol), regions in Austria, Luxemburg, and Switzerland. It is planned or being discussed to establish new cohorts (n around 100,000) with study protocols that to a very large extent will be standardized with those of the National Cohort (see Sect. A.3.8). 18
A.1.8 Preparatory work for the National Cohort 19 A.1 Introduction and overview Since 2009, the planning and preparation of the National Cohort has been underway. The most important activities are summarized in Table 1.5, for details see Part B. Table 1.5: Preparatory activities for the National Cohort Activity Time General Funding of pilot phase within Helmholtz (after international review) 2008-13 Preparatory workshop with universities in Heidelberg (220 participants, 180 abstracts) 2008 Epidemiologic planning committee (EPC) established (members from Helmholtz and universities, guests) 2009 Project management team (PMT) established (at Helmholtz) 2009 Thematic working groups established (17 topics, over 230 members, 3/4 from universities) 2009 Decision on clusters and study centers for field work (after international review) 2009 Ad hoc working group on governance and financing (between BMBF and Federal States) 2010 Funding of feasibility study for universities by BMBF (complementary to funding within Helmholtz) 2010-12 Ethical clearance for feasibility study from ethics committee Munich 2010 Discussion of draft of data safety concept with federal and state data protection officers (in Wiesbaden) Level 1, level 2 2010 Several planning visits of UK Biobank (at Imperial College, field work in London) 2010 Planning visit of LifeGene (at Karolinska Stockholm) 2009 Planning visit from CONSTANCES (at HMGU Munich) 2010 Planning visits for biorepository (at UK Biobank Manchester, Karolinska Stockholm, several providers) MRI program 2009-10 Several planning visits of UK Biobank (at Imperial College London) 2010 International planning workshop (at Helmholtz Berlin) 2010 A.1
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