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ACTIONACTIONAccelerating Clinical Trials Integration and Overcoming Non-value-add
Kelly PaulsonMayo Clinic Cancer Center
Accelerating Clinical Trials Integration and Overcoming Non-value-add
Kelly PaulsonMayo Clinic Cancer Center
• Purpose: Improve performance of key processes associated with conducting clinical trials that are PI initiated with industry support• Goal: 20% reduction; anticipated: 50%
reduction
• Timeline: January – December, 2009
• Collaborative effort with Cancer Center, IRB, Legal, Budgeting
• Purpose: Improve performance of key processes associated with conducting clinical trials that are PI initiated with industry support• Goal: 20% reduction; anticipated: 50%
reduction
• Timeline: January – December, 2009
• Collaborative effort with Cancer Center, IRB, Legal, Budgeting
Project Introduction
What Worked Well - ProjectWhat Worked Well - Project
• Dedicated Project Manager and Quality Improvement Expert
• Active involvement from major players (IRB, Legal, physicians, etc.)
• Voice of the customer
• Ongoing communication
• DMAIC process
• Metrics
• Dedicated Project Manager and Quality Improvement Expert
• Active involvement from major players (IRB, Legal, physicians, etc.)
• Voice of the customer
• Ongoing communication
• DMAIC process
• Metrics
What Worked Well - ProjectWhat Worked Well - Project
• Dedicated IT resources & website
• Recognize what you cannot/should not change
• Value stream maps – visual representation
• Sharing responsibility/accountability among the 10 teams
• Dedicated IT resources & website
• Recognize what you cannot/should not change
• Value stream maps – visual representation
• Sharing responsibility/accountability among the 10 teams
Project TeamsProject Teams• Protocol Development
• Budgeting
• Disease Oriented Groups
• Protocol Activation
• Case Report Forms
• Training
• Ancillary Committees
• IT
• Internal Communications
• External Communications (Sponsors)
• Protocol Development
• Budgeting
• Disease Oriented Groups
• Protocol Activation
• Case Report Forms
• Training
• Ancillary Committees
• IT
• Internal Communications
• External Communications (Sponsors)
What Worked Well – ChangesWhat Worked Well – Changes
• Earlier start
• Combining activities/forms
• Standardize processes
• Eliminate duplication/manual processes
• Eliminate PI admin responsibilities
• Creating templates/training materials/dashboards
• Earlier start
• Combining activities/forms
• Standardize processes
• Eliminate duplication/manual processes
• Eliminate PI admin responsibilities
• Creating templates/training materials/dashboards
ChallengesChallenges
• Staying committed to deadlines along with other work obligations
• Training
• Accountability – sustaining changes
• Some processes are out of our control
• Staying committed to deadlines along with other work obligations
• Training
• Accountability – sustaining changes
• Some processes are out of our control