2-day In-person Seminar How to design and to interpret a clinical trial in the targeted therapies Era

Overview:
The seminar will mainly focus on critical points related to clinical trials.

Areas Covered in the Session:
• Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints...)
• Introduction of targeted therapies in the Oncology field and of the related different needs (i.e. identification and validation of biomarkers). Examples will be provided about the most important types of tumors (lung cancer, colorectal cancer, breast cancer), as well as the more rare diseases.
• Analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided.
• Requirements of the regulatory authorities, with a special focus on the rebounds in the European and Italian System (with examples of major criticisms of some relevant trials)
• Meaning of the terms deviation, violation and exception and their impact on the clinical trials conduction and results.
• Phase III statistical design of clinical trials in Oncology, in particular with new drugs (analysis of recent examples of phase III trials which present limitations).

Event Link - http://bit.ly/1Ad48vR