PTI - international

Agenda: Day One

I. Introduce Clinical Trial Performance Metrics

• Call for action: Why do you need to implement metrics?
• Understand the value of metrics implementation 
  • utility as a management or decision making tool 
  • enabling benchmarking with other industry
  • increasing effective communication
  • providing opportunities for early problem identification and correction
  • permitting consistent tracking of identified project objectives
• Identify and define common terms and acronymsStructure and reader expectation

Exercise: Discuss Participants' Backgrounds and Course Expectations

II. Identify Metrics that are Useful as Indicators of Clinical Trial Performance

• Select meaningful and well-defined metrics
  • is the metric relevant?
  • is the metric actionable?
  • what is the significance of fundamental processes versus critical outcomes?
  • is the metric reasonably available?
• Identify metrics drivers
• Compare practical metrics with key metrics
• Can metrics be standardized within the industry?

III. Determine Which Types of R&D Metrics Matter

• Identify business intelligence needs: key focus areas 
  • scope 
  • data quality
  • risk
  • investigator performance and data quality
  • timeliness
  • cost
  • staff performance 
• Differentiate types of measurement systems
  

Exercise: Analyze Example Companies' Metrics Programs

IV. Make Your Metrics System Work: Develop Strategy Maps

• Decide upon goals
• Identify metrics for each operational department
• Map processes
• Select measurement criteria
• Define the metric and way measurements will be taken
• Other tips and tricks for making your metric system work
  

Exercise: Critique an Example Strategy Map
Exercise: Develop a Map for a Personal Goal  and Discuss

V. Introduce Tracking Systems

• Discuss the utility of implementing a tracking metric system
  
• Distinguish internal versus external metrics and control points
  
• Analyze types of tracking metrics and related examples
  
• Create a balanced set of metrics
  

Exercise: Develop, Discuss and Critique Performance Metrics for Example Companies

VI. Apply Earned Value Metrics

• Define the purpose of implementing earned value metrics
• Analyze the standarlized approach
• Measure EVA

Exercise: Use EVA for Enrollment Performance Tracking