At the end of this course, the student can:
• describe clinical research as a structured process of knowledge generation for clinical scientific theory
building and evidence based medicine and recognize these aspects in a specific clinical research topic.
• describe concepts of measurements for quantification of experimental or clinical variables and of their
validity, reliability and generalizability and apply these insights to studies within a specific clinical research
topic.
• describe several aspects and types of clinical study design – such as observational and experimental designs
- and their validity in the context of a clinical research question and apply these insights to studies within a
specific clinical research topic.
• describe methods and rationale for describing clinical data or phenomena based on statistical analysis and
their consequences for testing the effect of experimental or clinical interventions, and apply these insights to
studies within a specific clinical research topic.
• describe methods for assessment of diagnostic accuracy based on statistical analysis and apply these insights
to a specific example of clinical research topic. propose a next step in knowledge generation for a specific
clinical research topic by motivating a new research question, study design, essential measurements, and
interpretation of results.
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Clinical research is the systematic process of examining clinical conditions and outcomes, in order to establish relationships among clinical phenomena and to generate evidence for decision making toward improved clinical practice. As a Biomedical Engineer, you will continuously encounter clinical research, either by performing a clinical study yourself or by using the results of clinical research for development or validation of new technologies or medical devices. Furthermore, you will frequently be working with professionals for whom clinical research is a main source of knowledge toward theory building and clinical innovation - c.f., evidence based medicine. This course will provide the foundations of clinical research by addressing key aspects of theory building, concepts of measurements, study design, interpretation of data. Students will assess and interpret clinical methods and results and use clinical results for developing new concepts or for assessment or validation of new technology. The course consists of lectures disclosing the structure of the subject material, explaining approaches and concepts and providing illustrative examples from the clinical research practice. During the course, students will build a portfolio based on assignments for application of the theory on a specific clinical research topic of interest and participate in peer groups for providing mutual feedback and receiving feedback from a tutor. This feedback is processed into the final version of the portfolio, which is graded at the end of the course. The final assignment in the portfolio will be a brief research proposal, to be presented to fellow students.
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