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)

Value Stream MapValue Stream Map

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

Training PathwayTraining Pathway

Protocol Management ToolProtocol Management Tool

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

Questions?Questions?