Module EW4250-KP06

Duration

1 Semester

Turnus of offer

each summer semester

Credit points

6

Course of studies, specific fields and terms:

• Master Nutritional Medicine 2023, compulsory, interdisciplinary competence
• Master Nutritional Medicine 2019, compulsory, interdisciplinary competence

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

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

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

Grading through:

• portfolio exam

Requires:

• Clinical Studies (MA2214-KP04, MA2214)

Responsible for this module:

• PD Dr. Britta Wilms

Teacher:

• Institute for Experimental Endocrinology
• MitarbeiterInnen des Instituts
• PD Dr. Britta Wilms
• Dr. Marcel Pointke

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

Language:

• German and English skills required

Notes:

Last Updated:

27.03.2024