791365 Clinical studies (in Eng.)

Vorlesung und Seminar
Vortragende/r (Mitwirkende/r)
Blöchl-Daum, Brigitte , Brunner, Martin , Zeitlinger, Markus
Angeboten im Semester
Wintersemester 2018/19
Unterrichts-/ Lehrsprachen


Clinical Trials and Drug Development
From "First in Man" to "First on the Market"

Modul 1
Why do we need clinical trials?
Study-Design and Methodology
Randomisation Stratification..
Different study types
Choice of Comparator
Placebo and Assay Sensitivity
Precision, Accuracy, Bias, Confounder

Modul 2
Phases of Clinical Research
Surrogate versus Clinical Endpoint
Good Clinical Practice Guidelines
Data-Handling Adverse Events

Modul 3
Ethics committee
Study protocol
Inclusion Exclusion Criteria
Case Record Forms
Life cycle of a drug

Modul 4
Ethics of clinical research
Historic background,
Patient protection - Declaration of Helsinki,
Patient Information and Informed consent
European Medicine Agency - Centralized Marketing Authorisation
Research Misconduct and Fraud


Master Biotechnologie - Schwerpunkt Medizinische Biotechnologie
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