Estudio del marco normativo de los ensayos clínicos en España

Zusammenfassung

Clinical Research provides medical knowledge through the study of drugs in human beings, being the link between basic research and patient care. The data from this type of research allows obtaining marketing authorization for new drugs from the different regulatory agencies.This doctoral thesis with industrial mention reviews the need for the existence of clinical research, its evolution over time, as well as the legal regime of clinical research in Spain in the Spanish legal system through five completely different chapters, with a common thread that seeks to analyze the development of clinical research to date, as well as to indicate new possible areas of focus and/or improvement in the legal tools, or in the processes carried out in clinical research...