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The course will focus in particular on drug trials, which for various reasons set the gold standard in evidence-based medicine and the ethical and regulatory requirements for clinical trials. The lecturer has also worked in commercial drug development for many years. Many real examples and case studies will therefore be used to learn the basics of such studies and to discuss ethical issues. Studies from very different indications will be covered and topics such as diversity (ethnic, sex/gender, age groups), vaccination studies, gene therapy/genome editing, role of AI will also be discussed. We will recognize how a regulatory framework helps to ensure the well-being of the study participants and furthermore the integrity and quality of the trials, their data and the resulting scientific findings and conclusions. Clinical Trials: • Interventional vs. non-interventional studies • Trials involving medicinal products / Phases of drug development • Study objectives • Typical study designs • Randomization, blinding, study documentation, sample size determination Good Clinical Practice (GCP) and Research Ethics: • Ethical principles for research • History of clinical research ethics (incl. case studies) • Good Clinical Practice guidelines / legal framework • Roles, tasks and responsibilities in clinical studies as defined by ICH-GCP • Patient information and consent • Clinical trial application / Ethics committees / Competent authorities • Scientific requirements and practical implementation issues • Quality management in clinical trials • Patient information and consent • Data collection and handling / Statistical planning and analysis • Adverse events and safety reporting |