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Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution

Track:
Clinical Operations

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
378

Room Number:
2

Level:
Intermediate

Type:
Symposium

Title:
Optimize Protocol Design: A Path to Efficient, Lower Cost Trial Execution

Chair(s):
Larry A. Blankstein, PhD
Senior Director, Clinical Research
Genzyme Corporation, A Sanofi Company, United States

Description:
This symposium will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and study complexity. Each speaker will discuss the key factors to consider when developing protocols to minimize complexity while ensuring trial success.

Learning Objective(s):
Identify the key elements of an effective protocol design process that can reduce the number of amendments and study costs; Describe the key factors that contribute to study complexity and operational challenges and how to manage their impact on study execution; Discuss how to assess what critical data should be collected to support a study’s endpoints.

Presentation(s) & Speaker(s):
Implementing a Protocol Design Process to Reduce Cost, Complexity, Risk, and Duration
Igor Gary Altman
Senior Director, Product Management
Medidata Solutions Worldwide, United States

Quantifying the Magnitude and Cost of Gathering Nice to Have Data
Stella Stergiopoulos
Senior Project Manager
Tufts Center for the Study of Drug Development, United States