DIA 48th Annual Meeting
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Clinical, Statistical, and Data Management Considerations for Developing Clinical Trial Protocols
Track
:
Track 01: Clinical Operations
Program Code:
347
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Suresh Siddhanti, Amgen Inc., United States
PRESENTER
(S):
Robert Kane, FDA, United States
Sunil Gupta, Sanofi Oncology, United States Sylvia Engelen, Bayer Healthcare Pharmaceuticals, United States
Description
Experts from FDA and industry will provide insights on the key aspects of developing a phase 3 clinical trial protocol. They will also discuss the impact of standardization of data collection terminology during the clinical development program.
Learning Objectives:
Discuss global regulatory considerations in designing and writing a phase 3 clinical trial protocol
Explain the importance of defining the study objectives and endpoints
Discuss approaches to standardizing terminology used in clinical trial program.
Learning Objectives:
Discuss global regulatory considerations in designing and writing a phase 3 clinical trial protocol
Explain the importance of defining the study objectives and endpoints
Discuss approaches to standardizing terminology used in clinical trial program.
This session is a part of:
Handout Online
