2011 ACRIN Annual Meeting

ACRIN ACCELERATED ACCRUAL DEMONSTRATION PROJECT

Department of RadiologyThe University of Iowa

Carol Mertens, Ph.D., CFLE, LMHCPrincipal Investigator

W. Allen McGruderDepartmental Research RA

2011 ACRIN Annual Meeting

ACKNOWLEDGEMENTS

• Sincere thanks & appreciation to:

– Dr. Laurie Fajardo, MDRadiology Department ChairThe University of Iowa

– Lisa Lang, BLS, CRAResearch AdministrationDepartment of Radiology, U of I

2011 ACRIN Annual Meeting

ACKNOWLEDGEMENTS

• Sincere thanks & appreciation to:

– Nancy Fredericks, MBADirector, ACRIN Communications

Project Leader, Accelerated Accrual

– Cynthia Olson, MBA, MHSRESCUE Project Manager

2011 ACRIN Annual Meeting

ACCELERATED ACCRUAL AT UNIVERSITY OF IOWA

Our proposal focuses on a team collaboration approach spearheaded by a Departmental Clinical Research Coordinator (DCRC) charged with the overall coordination of all ACRIN-based clinical imaging trials and initiatives within the department.

2011 ACRIN Annual Meeting

U of I Proposed Overall Strategy

We proposed that modeling and employing a team approach would provide a more efficient and productive research environment that is conducive to replication and implementation across ACRIN sites.

• Elements of team approach:– Enhanced communication, – Shared knowledge and expertise, – Outreach to team members, and – Acknowledgement & Appreciation

2011 ACRIN Annual Meeting

DCRC

• Not committed to one single trial or PI

• Brings expertise to all ACRIN clinical trial teams:– Works to determine trial feasibility

– Trial preparation and activation responsibilities

– IRB application & regulatory items

– ACRIN research protocols/organizational initiatives

– Oversees open trials on a macro-basis

– Radiology Research Support Group

2011 ACRIN Annual Meeting

DCRC

• Work in partnership with Department of Radiology Imaging Research Cores and University of Iowa Carver College of Medicine Research Support Cores to:

– establish trial-specific research teams for each ACRIN trial conducted at University of Iowa and

– coordinate regular ACRIN trial meetings, monitor trial accrual, data submission, and timelines.

2011 ACRIN Annual Meeting

DCRC

• Serve as University of Iowa liaison with ACRIN

• Key person in successful organization and start-up of ACRIN trials at the University of Iowa.

• Assist with remote monitoring and on-site audits by ACRIN

2011 ACRIN Annual Meeting

DCRC

• Serve as the Regulatory Specialist by coordinating regulatory requirements with ACRIN and/or other committees within the University (i.e. Safety, Pharmacy, etc.)

• Conduct periodic reviews of potential issues inherent in research trials – Regulatory– Compliance– IRB reviews

2011 ACRIN Annual Meeting

ULTIMATE GOAL

• Promote collaboration among departmental research team members by modeling a team approach to sharing “best practices”

• Large Group: Radiology Research Support Group

• Small Group: Trial Specific Small Group Meetings

© 2011 The University of Iowa Hospitals and Clinics Department of RadiologyConceptual design: Carol Mertens, Joe Ekdahl & Alan McGruder with assistance from the Radiology Research Support Group

DCRC contact: e-mail: carol-mertens@uiowa.edu, phone: 319-384-9850

Departmental Clinical Research Coordinator

&RA Support

Imaging Data Management Safety Content Experts Multi-disciplinary

Research Personnel

Accelerated Accrual Demonstration ProjectCollaborative Support ModelThe University of Iowa Department of Radiology

2011 ACRIN Annual Meeting

Demo Project: RESCUE

• RESCUE Status:– Member of “Rapid 10”—# 7!!!– “Most challenging site” – Launching Lunch: 28 JUN 2011– First patient enrolled: 27 JUN 2011– Two presentations at ACRIN

2011 ACRIN Annual Meeting

SELECTED OUTCOMES

• Small group team meeting format very helpful in trial start-ups

• Dubbed as “most challenging RESCUE site”—reflection of questions generated during RESCUE team meetings

• Mean days from submission to release of IRB approval below IRB average (68 vs.79).

2011 ACRIN Annual Meeting

U of I Full Board New StudiesMean Days: Submission to Release 2008-2010

05

101520253035404550

UI AVGHSO DAYS

RESCUEHSO DAYS

UI AVG PIDAYS

RESCUE PIDAYS

2011 ACRIN Annual Meeting

SELECTED OUTCOMES

• RESCUE Rapid Ten: Site # 7

• Fantastic teamwork, support, and interest in the Accelerated Accrual Project and RRSG!

• RRSG—Radiology Research Support Group

– Great forum to exchange information and generate ideas!

2011 ACRIN Annual Meeting

Replication and Commitment

• Departmental Funding of DCRC Position: The Department of Radiology intends to provide partial funding for this position, employing a graduated budget which stipulates the following strategy for funding the DCRC salary:

Year One: 65% ACRIN Accelerated Accrual Budget 35% Department of Radiology Supported

Ends 12/31/2011

Year Two: 50 % Clinical Trials Supported 50% Department of Radiology Supported

Department has committed to the second year

Year Three: 75% Clinical Trials Supported 25% Department of Radiology Supported

Department intends to fulfill 3rd year commitment

2011 ACRIN Annual Meeting

ORIGINAL MOTTO

• A = ACRIN:

• T = TOGETHER

• E = EACH

• A = ACCOMPLISHES

• M = MORE

2011 ACRIN Annual Meeting

RESEARCH TEAMS FOSTER

• RESPONSIBILITY–Who does what?–Where are they in the process?–How can we support them?

• DIRECTION–Are we on the right track?–Are we moving toward the goal of the protocol?

2011 ACRIN Annual Meeting

RESEARCH TEAMS FOSTER

• OWNERSHIP–We all have a role/part in the study–The contributions and ideas provided by team members create ownership of project

• SOLIDARITYBrainstorming solutions as a team has promoted CAMARADERIE in both large and small research group settings.

2011 ACRIN Annual Meeting

Testimonials

• “Having a (DCRC) for (the RESCUE) study has taken the ethics workload away from our group so we are able to focus on recruitment, enrollment and retention.”

– Kim Sprenger, CRC, RESCUE CRTeam Department of Internal Medicine

University of Iowa Hospitals & Clinics

2011 ACRIN Annual Meeting

Testimonials

• “(The RESCUE project) truly is a great team effort and it is wonderful to have the collaborative support of (the U of I RESCUE) team and the ACRIN team!”

– Janet Keating, Lead RA, RESCUE CRTeam Department of Internal Medicine

University of Iowa Hospitals & Clinics

2011 ACRIN Annual Meeting

MOTTO ADDENDUM

TEAM WORK

IS

BRAIN FOOD!!