Andrea Burden: Catalogue data in Autumn Semester 2022
|Name||Prof. Dr. Andrea Burden|
Professur f. Pharmakoepidemiologie
ETH Zürich, HCI H 407
|Telephone||+41 44 633 74 09|
|Department||Chemistry and Applied Biosciences|
|Relationship||Assistant Professor (Tenure Track)|
|395-0101-00L||Modern Study Concepts |
Only for CAS in Modern Concepts in Clinical Research and MAS in digital Clinical Research
|1.5 credits||1G||A. Burden, S. Goldhahn, further lecturers|
|Abstract||In the course, participants are introduced to established study designs and study elements, as well as to modern study concepts and observational designs to address clinical questions. Another focus is on patient perspectives and patient preference studies.|
|Objective||Participants will learn about alternatives to classic trial designs such as advanced study types and patient involvement and will integrate them into their own clinical study planning at the end of the module. |
The course enables participants to...
1. describe the drug approval process, with a focus on Phase III clinical trials, identify the shortcomings of Phase III trials, and describe the strengths and limitations of Phase IV (observational drug safety) research.
2. identify and describe advanced study designs in observational research, explain the advantages and disadvantages of these designs, and identify what research questions are most suited to the advanced research questions.
3. explain the importance of randomisation in the assessment of moderate treatment effects, understand the principles of streamlined clinical trial design, understand how novel data sources can be used to provide reliable randomised evidence.
4. understand patient perspective as an integral part of clinical trials and clinical decision-making, understand the research process of a patient preference study, and recognise the similarity of the scientific principles of preferences studies with other study types.
5. describe the difference between including versus involving patient and family stakeholders in research studies, identify different ways to involve patient stakeholders into research, name ethical principles underlying the involvement of patient stakeholders in research.
6. describe how advanced study types and/or patient perspectives can be integrated into their individual clinical research planning.
|511-0007-00L||Scientific Writing and Presenting |
Only for Pharmaceutical Sciences MSc.
|2 credits||2G||J. A. Hiss, A. Burden, J. Dolenc, J.‑C. Leroux, O. Renn, C. Steuer|
|Abstract||This introductory class provides an overview of the basic scientific writing techniques and a guideline to presenting scientific data, together with guided exercises and hands-on training. It is devised to accompany the research projects within the curriculum of the MSc in Pharmaceutical Sciences.|
|Objective||The class enables the participants to prepare their own scientific texts and oral presentations, and critically assess the quality of the presentation of scientific data.|
|Content||The participants receive an introduction to basic formal aspects of scientific writing and the design of graphical elements. Lectures and topical seminars alternate with practical task for the participants, which will be evaluated in a peer-to-peer setting. Performance feedback is provided by both the teachers and the peers.|
|535-0011-00L||Drug Seminar |
The course is reserved for students registered in the Master's programme in Pharmacy or in Pharmaceutical Sciences
|5 credits||9S||J. Hall, A. Burden, K. Eyer, C. Halin Winter, S.‑D. Krämer, J.‑C. Leroux, C. Müller, V. I. Otto, U. Quitterer, J. Scheuermann, R. Schibli, K. Silina, C. Steuer|
|Abstract||The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences. Students work in small groups on a chosen topic, they write a mini-review and present their work on a one day symposium.|
|Objective||The main objectives of this course are: |
- students develop their scientific reflection (Critical Thinking) and working skills by working independently on a relevant pharmaceutical topic
- students gain in-depth knowledge of the topic investigated
- students train their scientific writing and presentation skills
- students train their ability to plan a project and work in a team
|Content||The Course Drug Seminar takes place during the first 7 weeks of the 1. Master semester. It is a compulsory course of the MSc Pharmacy curriculum and an elective course in the MSc PharmSciences. |
The course provides a platform for the investigation, presentation and discussion of a topic with relevance to the field of pharmaceutical sciences.
During the course, students work in small teams on a topic of their choice and elaborate a written mini-review and an oral presentation. Each team is tutored by a lecturer of the Institute of Pharmaceutical Sciences. The work is mainly based on literature search / review, but may also involve conducting interviews or site visits, if appropriate. The final presentations of all groups will take place in the framework of a dedicated Symposium held in the middle of the semester.
|Prerequisites / Notice||Only for students of MSc Pharmacy and MSc Pharmaceutical Sciences.|
|535-0050-00L||Pharmacoepidemiology and Drug Safety||3 credits||2G||A. Burden, S. Russmann|
|Abstract||Introduction to the principles, methods and applications of pharmacoepidemiology and drug safety. Drug safety in the pharmaceutical industry and regulatory authorities, but also for hospital and office pharmacists. Another focus is the evaluation and interpretation of pharmacoepidemiological drug safety studies in the medical literature and the evaluation of benefits vs. risks.|
- To familiarize participants with the principle methods and applications of pharmacoepidemiology and drug safety that is relevant for industry, regulatory affairs, but also for clinical pharmacists in hospitals and office pharmacies.
- Perform independently a causality assessment of suspected adverse drug reactions in patients
- Study designs and biostatistics used for the quantitative evaluation of drug safety
- Setup of programs that can effectively reduce medication errors and improve drug safety in clinical practice, particularly in hospitals
|Content||- Historical landmarks of drug safety|
- Pharmacovigilance and causality assessment
- Drug safety in premarketing clinical trials
- Descriptive, cohort and case-control drug safety study designs; Data analysis and control of confounding
- Pharmacoepidemiology and regulatory decision making in drug safety; Risk management plans (RMPs)
- Medication errors, clinical pharmacology / clinical pharmacy
- Clinical Decision Support Systems, Interventional Pharmacoepidemiology
- Pharmacoepidemiological databases, 'Big Data'
- Interactive discussion of many real-life examples for each topic
|Lecture notes||This course will be a combination of formal lectures, group discussions and self-directed studies. Course material will be taught through seminars, case studies in small groups.|
Reading material and scripts will be provided for each week.
- Rothman: Introduction to Epidemiology
- Strom, Kimmel, Hennessy: Textbook of Pharmacoepidemiology
- Gigerenzer: Risk Savvy - How to Make Good Decisions