2-day In-person Seminar How to Design and to interpret a Clinical Trial in The Targeted Therapies Era
About This Event
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).
Who Will Benefit:
This seminar will provide valuable assistance to Companies, CROs, Investors and Professionals, including Physicians and Payers. Those that would benefit most would be:
• Companies involved in the development of new anti-cancer drugs
• Professionals involved in the design of clinical trials in Oncology
• Production Managers
• Monitors
• CROs
• Investors
• Medical Oncologists
Agenda
Day One
Lecture 1: Targeted therapies in Medical Oncology - big killers
Lecture 2: Targeted therapies in Medical Oncology - rare tumors
Lecture 3: Traditional statistical design of clinical trials in Oncology
Lecture 4: New clinical trials design in Oncology
Lecture 5: Q & A
Day Two
Lecture 1: Requirements of regulatory authorities
Lecture 2: New endpoints, impact of deviation, violation and exception on clinical trials
Lecture 3: Critical analysis of phase III trials - part 1
Lecture 4: Critical analysis of phase III trials – part 2
ABOUT SPEAKER:
Rossana Berardi
Consultant Medical Oncologist and Lecturer, University Hospital
Rossana Berardi, MD is a Consultant Medical Oncologist and Associate Professor at University Hospital. She is also the Responsible of the Trial Unit at Dept of Oncology - Universita Politecnica Marche - Italy. Dr Berardi usually deals with about 35 GCP trials/year with new drugs mainly in lung and GI cancer.
DATE AND VENUE:
Location 1: Las Vegas, NV | January 22rd & 23rd, 2015| 9:00 AM to 6:00 PM PST
Venue: Hilton Grand Vacations Suites at the Flamingo 3575 Las Vegas Boulevard South, Las Vegas, Nevada (89109)
Price: $1,295.00
Contact Information
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