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Perfecting the Protocol: Designing Studies for Success

Track:
Clinical Operations

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
281

Room Number:
1B

Level:
Basic

Type:
Symposium

Title:
Perfecting the Protocol: Designing Studies for Success

Chair(s):
JeanMarie Markham
Chief Executive Officer
Clinlogix, United States

Description:
This symposium will help you understand if the inclusion/exclusion criteria for your company’s protocol are too restrictive, discuss recent trends in study endpoints and clinical outcome measures, and also discuss what data and experience CROs can use to help you assess the best balance between speed and cost.



Learning Objective(s):
Recognize the telltale signs of an unworkable protocol; Assess evolving trends in study endpoints and clinical outcome measures in clinical trials including how they may correlate with trial success; Describe what data CROs have that are helpful to sponsor protocol decision-making.

Presentation(s) & Speaker(s):
How CROs Can Better Support Sponsor Protocol Development
Jeffery Fairbairn, MBA
Senior Director, Partnership Office
PAREXEL International, United States

Hunting a Needle in the Haystack? But It’s All Straw! Are There ANY Subjects that Match the Inclusion/Exclusion Criteria?
John E. Humphreys, MS
Senior Product Manager, Clinical Trial Optimization Solutions
IMS Health, United States

Designing for Success? Recent Trends in Study Endpoints and Clinical Outcome Measures in Autoimmune and Inflammatory Diseases
Sylvia Marecki, PhD
Senior Director, Product Management & Strategy
Citeline, United States