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395-0101-00L 1.5 Credits NDS , WBZ D-HEST

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Modern Study Concepts

Lecturers & Examiners: Prof. Dr. Andrea Burden, Dr. Sabine Goldhahn

Only for CAS in Modern Concepts in Clinical Research and MAS in digital Clinical Research

VVZ CR n/a

Last Updated: 2026-02-05 16:01:57

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.

General Information

Language: English
Levels: NDS , WBZ
Frequency: Yearly recurring

Examination

Type: ungraded semester performance

Registration & Places

Priority: Registration for the course unit is only possible for the primary target group

Course Components