Clinical Research

Module One – Basics of Clinical Research – Theory* Introduction to Clinical Trials, Theory of Study Conduction Methods, Principles of Statistical Analysis, Designing a Clinical Trial, Principles of Trial Management and Study Types How to formulate a research question (FINER, PICOT) Select study population (inclusion/exclusion criteria) Randomisation Blinding methods and unblinding problems Statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data imputation and meta-analysis) Data collection (electronic capture) Data monitoring (interim analysis, DSMB) Scientific reporting (include training in manuscript writing) Types of study designs and clinical study phases (observational studies, non-inferior and adaptive designs and randomised clinical trials, phase 0 to IV) *Module One includes the content of the PPCR programme – a recognition of the programme is possible. Module Two – Advanced Clinical Research – Applications Applied Biostatistics, Data Visualisation, Hands-On Workshop on R/RStudio Applied biostatistics and clinical practice Data visualisation, data and data sources R/RStudio hands-on workshop Module Three – Innovations of Clinical Research Scientific Presentation, Handling of Modern Media, Health Economic Outcome Research, Big Data and AI, Real-World Data / Real-World Evidence, Health Technology Assessment Scientific presentation Handling of modern media Health economic outcome research Big data and artificial intelligence (AI) Real-world data ("RWD") / real-world evidence ("RWE") Health technology assessment ("HTA")