Duration:
1 Semester | Turnus of offer:
each summer semester | Credit points:
6 |
Course of studies, specific field and terms: - Master Nutritional Medicine 2023 (compulsory), interdisciplinary competence, 2nd semester
- Master Nutritional Medicine 2019 (compulsory), interdisciplinary competence, 2nd semester
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Classes and lectures: - Design and realization of clinical studies (exercise, 1 SWS)
- Design and realization of clinical studies (seminar, 1 SWS)
- Design and realization of clinical studies (lecture, 2 SWS)
| Workload: - 90 Hours private studies
- 60 Hours in-classroom work
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Contents of teaching: | - What is a clinical trial Definitions/ Examples
- Different types of trial
- Ethical issues.
- Blindness.
- Planning the trial: formulation of hypotheses.
- Explanatory and pragmatic approaches: clinical trials as hypothesis testing and decision procedures.
- Choice of outcome measures and implications for analysis.
- Selecting patient populations and samples.
- Obtaining and maintaining comparable patient groups: selection, allocation and assessment biases and their avoidance.
- Allocation to treatment: simple, restricted and stratified randomisation; minimisation
- Extensions: cluster randomised trials, crossover trials, equivalence trials, factorial trials and meta-analysis.
- Introduction to Phase 2-3 Designs
- Trial Critiques.
- Superiority and non-inferiority trials
- CV-outcome studies (endpoint studies) vs. safety trials
- Drug regulatory perspectives on clinical trial design, conduct, analysis and interpretation
- Design and analysis issues in crossover trial designs
- Design and analysis issues in cluster trial designs
- Meta-analysis of clinical trial data
- Inclusion of economic evaluation in or with trial designs
- An introduction to personalised medicine
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Qualification-goals/Competencies: - Students are able to understand the principles and rationale of clinical trial design and conduct
- The students can appreciate some special problems of analysis and interpretation of clinical trials results, and the ways in which good experimental design can help avoid these
- Students can appreciate the ethical and regulatory issues surrounding clinical trials & their use in health technology assessment
- They understand specific design issues in clinical trials, including; inclusion/exclusion criteria, blinding, and randomisation
- They understand and calculate the sample size required for a clinical trial
- They are able to carry out an extended piece of statistical analysis using computer software
- They can summarise and interpret the results of a statistical analysis for both a technical and non-technical audience
- They learn to deal with real and difficult analysis issues and to appreciate no single correct solutions exist
- They have a practical understanding of the methods covered in Clinical Trials
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Grading through: |
Requires: |
Responsible for this module: Teachers: - Institute for Endocrinology and Diabetes
- MitarbeiterInnen des Instituts
- PD Dr. Britta Wilms
- Dr. Marcel Pointke
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Literature: - Brody, T: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines - Elsevier
- Friedman, L.M., Furberg, C.D., DeMets, D.L: Fundamentals of Clinical Trials - Springer
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Language: - German and English skills required
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Notes:Admission requirements for taking the module:
- None (the competences of the modules listed under 'requires' are needed for this module, but are not a formal prerequisite).
Admission requirements for taking module examination(s):
- SoSe 2021: no prerequisites
- from SoSe 2022: active participation in the exercises in small groups as specified at the beginning of the semester
Module exam(s):
- EW4250-L1: Clinical Studies 2, portfolio exam consisting of: 40 points in the form of seminar paper/excersises and 60 points in the form of a written exam, 100% of the module grade
(Share of Nutritional Medicine in V is 100%)
(Share of Nutritional Medicine in S is 100%)
(Share of Nutritional Medicine in Ü is 100%) |
Letzte Änderung: 27.3.2024 |
für die Ukraine