How to Design a Clinical Trial in the Target Therapies Era: New Endpoints (HealthCare Training)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Sep 20, 2011 End Date/Time: Sep 20, 2011
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Description

This webinar will begin by reviewing the traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints, etc.). We will then look over the introduction of targeted therapies in the Oncology field and 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.

The presenter will also review the requirements of the regulatory authorities (FDA, EMEA). Finally, an analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided.

Areas Covered in the Seminar:

- Traditional statistical design of clinical trials in Oncology (phases of studies, standard endpoints, etc.)
- Introduction of targeted therapies in the Oncology field and 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.
Requirements of the regulatory authorities (FDA, EMEA).
- Analysis of the new endpoints related to the different mechanism of action of the new therapies will be provided.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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