Teachers: Stefano Vella, Betty Polikar
The general aim of this course is to explain the basic principles of clinical research/clinical development and the methodological aspects needed to assure the validity of the data generated. Upon an overview on research development from compound to drug, the first part of the course will guide students into clinical studies classification(interventional/non interventional), clinical phases requested by regulatory authorities and in-depth examination of the contents and structure of a Study Protocol and related topics (common designs, study population, objectives, endpoints, randomization, blinding). A detailed analysis of the Good Clinical Practice (GCP) will be done, focusing on the aspects that have direct impact on the processes ruling the clinical protocol implementation. The second part of the course will be structured as monothematic lessons, which will cover specific areas of clinical research, such as infectivology (the history of HIV treatment), oncology (multiple identities and multiple approaches), cardiovascular and rare diseases, providing real examples on design and execution of clinical trials. The GCPs will be presented making clear reference to all the laws and regulations that are linked with their practical application.Further focus will be dedicated to particular study designs (adaptive design, basket studies, target therapy studies), relationship between clinical outcomes and patient-reported outcomes (PROs), meaning of efficacy and effectiveness, clinical studies on medical devices and neutraceuticals. Biostatistics general principles will be also introduced in order to explain how to finalize an effective planning, collection, analysis and interpretation of clinical data. The course will include monothematic lessons, which will cover specific areas of clinical research, such as infectivology (the history of HIV treatment), oncology (multiple identities and multiple approaches), cardiovascular and rare diseases, providing real examples on design and execution of clinical trials.
