How to design and to interpret a clinical trial in the targeted therapies Era 2015 is a seminar that covers topics such as:
- Targeted therapies in the Oncology field and of the related different needs
- Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints...)
- 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)
- Analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided
- 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)
- Meaning of the terms deviation, violation and exception and their impact on the clinical trials conduction and results
How to design and to interpret a clinical trial in the targeted therapies Era 2015 is intended for:
- Professionals involved in the design of clinical trials in Oncology
- Companies involved in the development of new anti-cancer drugs
- Monitors
- Production Managers
- Investors
- CROs
- Medical Oncologists