...folgt

...folgt

Die Studierenden erhalten einen Überblick über Relevanz und Anwendungsfelder der Klinischen Epidemiologie und Pharmakoepidemiologie. Es werden die speziellen Herausforderungen sowie fortgeschrittene Methoden (u. a. emulated target trials) der Pharmakoepidemiologie erörtert und die Vor- und Nachteile von unterschiedlichen Datenquellen (national und international) besprochen. Die Nutzung von Kassendaten für die epidemiologische Forschung in Deutschland, die Konzipierung von pharmakoepidemiologischen Studien, die Pharmakovigilanz und weitere Anwendungsfelder der Klinischen Epidemiologie und Pharmakoepidemiologie, z.B. im Bereich der Krebsfrüherkennung, werden ebenfalls erörtert. Das erlernte Wissen wird für die kritische Bewertung sowie die Konzipierung von Studien im Bereich der Klinischen Epidemiologie und Pharmakoepidemiologie angewendet.

Die Studierenden erhalten einen Überblick über Relevanz und Anwendungsfelder der Klinischen Epidemiologie und Pharmakoepidemiologie. Es werden die speziellen Herausforderungen sowie fortgeschrittene Methoden (u. a. emulated target trials) der Pharmakoepidemiologie erörtert und die Vor- und Nachteile von unterschiedlichen Datenquellen (national und international) besprochen. Die Nutzung von Kassendaten für die epidemiologische Forschung in Deutschland, die Konzipierung von pharmakoepidemiologischen Studien, die Pharmakovigilanz und weitere Anwendungsfelder der Klinischen Epidemiologie und Pharmakoepidemiologie, z.B. im Bereich der Krebsfrüherkennung, werden ebenfalls erörtert. Das erlernte Wissen wird für die kritische Bewertung sowie die Konzipierung von Studien im Bereich der Klinischen Epidemiologie und Pharmakoepidemiologie angewendet.

Course lecturer: Prof. Dr. Krasimira Aleksandrova, PhD, MPH
Phone number: +49 421 218 56 816
Email: aleksandrovaprotect me ?!leibniz-bipsprotect me ?!.de

Course prerequisites
Knowledge of basic concepts in epidemiology and study designs.

Course Overview
This course will introduce the students to the basic principles and practices in molecular epidemiology as a rapidly developing field during the last decades driven by the novel biomedical discoveries at molecular and genetic level. The course will start with providing an overview of the contextual framework for establishing the molecular epidemiology as a new branch in epidemiology including the recent developments in the biomedical field. Throughout the course, the students will gain understanding on various practical aspects related to the use of biomarkers in epidemiological research. These include considerations of the type of biomarkers, the biosample collection, processing and storage, biomarker measurements, principles of quality control for laboratory assays, measurement error, validity and reproducibility of biomarker data. The students will get to know specific study designs that allow integration and analysis of biomarkers in epidemiologic research, i.e. nested case-control and case-cohort studies. They will learn to appraise issues in epidemiologic study design and analysis, incl. potential uses and limitations of biomarkers. The students will be also exposed to numerous examples of the application of biomarkers to the study of major chronic diseases. They will learn how to biomarkers are applied in different epidemiological research contexts, such as causal inference (i.e. using mediation and Mendelian randomisation) and risk prediction analyses (i.e. precision prevention and biomarker-based risk stratification). In addition, they will learn about specific applications of molecular and genetic biomarkers in various population groups. A specific emphasis will be put on the ethical and legal aspects in biomarker research. The course will conclude with discussing the recent developments in establishing large biobanks, the shifting from human genome to human exposome research and the increasing use of biomarkers measured using novel biotechnological platforms, incl. metabolomics, transcriptomics and proteomics. The lecture topics will be organised to combine theoretical and practical aspects of molecular epidemiology and will include multiple class exercises and discussions of specific research examples involving biomarkers.

Course Objectives

This course is aimed to provide a background for understanding the basic principles in molecular epidemiology designs, methods, analysis and interpretation. Upon successful completion of the course, students should be able to:
• Know the contextual framework, the principles and concepts of molecular epidemiology and the application of biomarkers in epidemiologic studies, including their strengths and limitations;
• Describe major challenges in collecting, storing and processing various biological samples for human population studies, as well as the ethical and legal considerations;


• Formulate a research question and prepare a study and analysis plan employing study designs in molecular and genetic epidemiology;
• Critically appraise research reporting data from molecular and genetic epidemiological studies from etiology to risk prediction;
• Know the new developments in the field of molecular epidemiology and the increasing use of large biobanks and ‘-omics’ technologies.


Course Materials
Recommended:
Molecular Epidemiology of Chronic Diseases by Chris Wild, Paolo Vineis, and Seymour Garte. Hoboken, NJ: John Wiley & Sons Inc., 2008.
Further materials and suggested readings will be provided during the course.

Course requirements
In-class paper discussions: Students will be asked to read an article that provides an example of uses of biomarkers to investigate associations of interest. The students will briefly present the study using a list of predefined questions. They should learn to address the appropriateness the research question, the methodological aspects related to the used study design, biomarker information and data analysis/interpretation.

Final project. Students will have an opportunity to choose from two possible formats for preparing a final project. The students will receive also suggested literature that they can use and specific instructions on how to structure their final project report.
Option 1: A research proposal for a molecular epidemiology study.
The students should develop a short project proposal to address a research question in the field of molecular epidemiology. It should describe the research background, the specific hypothesis and research objectives, the study design (study population, exclusion/inclusion criteria; sample collection; biomarker measurement), planned statistical analyses and potential study limitations. The students should demonstrate that they can clearly describe the research question, provide justification and supporting literature; make a proper study design choice and demonstrate critical thinking.
Option 2: Literature review on the use of a biomarker(s) for addressing a particular research question
The students will be offered specific topics and can make a choice for conducting a literature review addressing a specific research question. Using the guidelines of the preselected journals, they will plan and conduct a literature review in which they should clearly present the research question and identify gaps and existing inconsistencies that need to be addressed by the review. They will suggest a strategy for collecting the literature and appropriate methods and data presentation. The students should show that they can clearly describe the research question, provide justification and supporting literature; critically appraise used study designs and demonstrate critical thinking.

Final presentation:
Each student will be given the opportunity to present their final work as a 15 minute presentation + 5-10 min discussion and receive feedback.

Course lecturer: Prof. Dr. Krasimira Aleksandrova, PhD, MPH
Phone number: +49 421 218 56 816
Email: aleksandrovaprotect me ?!leibniz-bipsprotect me ?!.de

Course prerequisites
Knowledge of basic concepts in epidemiology and study designs.

Course Overview
This course will introduce the students to the basic principles and practices in molecular epidemiology as a rapidly developing field during the last decades driven by the novel biomedical discoveries at molecular and genetic level. The course will start with providing an overview of the contextual framework for establishing the molecular epidemiology as a new branch in epidemiology including the recent developments in the biomedical field. Throughout the course, the students will gain understanding on various practical aspects related to the use of biomarkers in epidemiological research. These include considerations of the type of biomarkers, the biosample collection, processing and storage, biomarker measurements, principles of quality control for laboratory assays, measurement error, validity and reproducibility of biomarker data. The students will get to know specific study designs that allow integration and analysis of biomarkers in epidemiologic research, i.e. nested case-control and case-cohort studies. They will learn to appraise issues in epidemiologic study design and analysis, incl. potential uses and limitations of biomarkers. The students will be also exposed to numerous examples of the application of biomarkers to the study of major chronic diseases. They will learn how to biomarkers are applied in different epidemiological research contexts, such as causal inference (i.e. using mediation and Mendelian randomisation) and risk prediction analyses (i.e. precision prevention and biomarker-based risk stratification). In addition, they will learn about specific applications of molecular and genetic biomarkers in various population groups. A specific emphasis will be put on the ethical and legal aspects in biomarker research. The course will conclude with discussing the recent developments in establishing large biobanks, the shifting from human genome to human exposome research and the increasing use of biomarkers measured using novel biotechnological platforms, incl. metabolomics, transcriptomics and proteomics. The lecture topics will be organised to combine theoretical and practical aspects of molecular epidemiology and will include multiple class exercises and discussions of specific research examples involving biomarkers.

Course Objectives

This course is aimed to provide a background for understanding the basic principles in molecular epidemiology designs, methods, analysis and interpretation. Upon successful completion of the course, students should be able to:
• Know the contextual framework, the principles and concepts of molecular epidemiology and the application of biomarkers in epidemiologic studies, including their strengths and limitations;
• Describe major challenges in collecting, storing and processing various biological samples for human population studies, as well as the ethical and legal considerations;


• Formulate a research question and prepare a study and analysis plan employing study designs in molecular and genetic epidemiology;
• Critically appraise research reporting data from molecular and genetic epidemiological studies from etiology to risk prediction;
• Know the new developments in the field of molecular epidemiology and the increasing use of large biobanks and ‘-omics’ technologies.


Course Materials
Recommended:
Molecular Epidemiology of Chronic Diseases by Chris Wild, Paolo Vineis, and Seymour Garte. Hoboken, NJ: John Wiley & Sons Inc., 2008.
Further materials and suggested readings will be provided during the course.

Course requirements
In-class paper discussions: Students will be asked to read an article that provides an example of uses of biomarkers to investigate associations of interest. The students will briefly present the study using a list of predefined questions. They should learn to address the appropriateness the research question, the methodological aspects related to the used study design, biomarker information and data analysis/interpretation.

Final project. Students will have an opportunity to choose from two possible formats for preparing a final project. The students will receive also suggested literature that they can use and specific instructions on how to structure their final project report.
Option 1: A research proposal for a molecular epidemiology study.
The students should develop a short project proposal to address a research question in the field of molecular epidemiology. It should describe the research background, the specific hypothesis and research objectives, the study design (study population, exclusion/inclusion criteria; sample collection; biomarker measurement), planned statistical analyses and potential study limitations. The students should demonstrate that they can clearly describe the research question, provide justification and supporting literature; make a proper study design choice and demonstrate critical thinking.
Option 2: Literature review on the use of a biomarker(s) for addressing a particular research question
The students will be offered specific topics and can make a choice for conducting a literature review addressing a specific research question. Using the guidelines of the preselected journals, they will plan and conduct a literature review in which they should clearly present the research question and identify gaps and existing inconsistencies that need to be addressed by the review. They will suggest a strategy for collecting the literature and appropriate methods and data presentation. The students should show that they can clearly describe the research question, provide justification and supporting literature; critically appraise used study designs and demonstrate critical thinking.

Final presentation:
Each student will be given the opportunity to present their final work as a 15 minute presentation + 5-10 min discussion and receive feedback.

Termine nach Vereinbarung mit den Studierenden.