Clinical Research Improvement in Systems and Processes Kickoff, January 15, 2015

Improve the clinical research process, enhancing value to our research faculty, staff, patients, the Charlottesville community and beyond.

Institutional Alignment Executive Vice President for Health Affairs, Richard Shannon, MD

Institutional Alignment School of Medicine, Dean Canterbury, MD An important outcome of the strategic planning process for the School of Medicine is that we want to invest more in clinical and translational research. In order to achieve that goal, we need to optimize our internal processes to support clinical investigators in their work.

Institutional Alignment Associate Vice President for Research, Dave Hudson, PhD: Clinical trials are an important component of our research portfolio, but are also important for many other reasons. We seek to improve our processes to provide support for our Principal Investigators and to allow them to focus on what they do best - research.

Institutional Alignment School of Medicine, Senior Associate Dean for Research, Margaret Shupnik, PhD This is the beginning of efforts to evaluate and streamline our current processes and infrastructure, and to identify areas for future investments. Your input is critical to the success of this project, and we appreciate your time and effort.

Participants in the process - us

Participants in the process - us Improve Efficiency Increase Visibility Educate and Increase Awareness Increase Throughput Reduce Turnaround Time Support Throughout the Entire Process Become the Institution of Choice for the Sponsors Increase Satisfaction Create Safe Environment Standardize and Simplify Processing Build Capacity Enhance Institutional Reputation

Sponsors Pfizer, 2009: Quality, Speed, Cost metrics The time from final approved protocol received at the site until the site enrolls first patient <= 100 days The time from final approved protocol received at the site until final contract signed <= 30 Days There is a significant opportunity to increase speed and decrease opportunity costs Think Lean AstraZeneca: focused on improving lives of patients speed the delivery of innovative new medicines to the people that need them Forte Research Systems, 2013: Metrics Help Demonstrate Success and Find Areas for Improvement

Our External Customers If it hadn t been for the trials, I would have been toast. http://youtu.be/ievuq5if2s0

Context and First Priority Focus Scientific Investigation Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness benefit patients. Clinical Trials First Priority Focus Research in epidemiology, physiology and pathophysiology, Health services, education, outcomes and mental health http://research.med.virginia.edu/clinicalresearch/participate-in-a-trial/what-is-medical-research/ Clinical Research

Initial Scope Scientific Investigation Start: Sponsor Contact or Start Writing Protocol Protocol Writing/Receiving Compliance Budgeting Billing Setup Contract Negotiation Set Up Study End: Patient can be Enrolled Conduct Study Close Out Study Clinical Research: Clinical Trial Clinical Trials Research Results

M. C. Escher

Implementation Plan (what) Lean Methodology: The relentless pursuit of value through the strategic elimination of waste. (Elliott Weiss, Professor of Business Administration, Darden School of Business) Lean training Value stream analysis: customers, value, current state, types of waste, opportunities to eliminate waste, ideal state, critical success factors Make the work visible and observe with respect A3 scientific method for problem solving

Implementation Plan (what) 90-day projects: Create milestones, A3s Prioritize and remove waste Standardize, optimize, & automate Unknown Known

Implementation Plan (who) Advisory Workgroup Stakeholders Departments/Centers: Amy Fansler, Leisa Gonnella, Bridget Graves, Dina Halme, Stacy Thompson, Jonathon Neel Principal Investigators: Patrick Dillon, Nathan Fountain, David Kaufman, Michael Salerno, Ron Turner Sponsor representation: Bob Meyer Clinical Trials Office: Amy Camblos, Jennifer Crosby, Kathy Richardson Institutional Review Board: Richard Stevenson Investigational Drug Services: Amy Adams, Lauren Benusa UPG Billing: Chris Allison SOM Billing: Angela Sherman Departments/Centers: Cricket Birks, Sandra Burks, Johanna Loomba, Goga Radakovic, Cathy Reniere Clinical Trials Office: Lori Elder Office of Grants and Contracts: Stewart Craig, Lynn Koplin Institutional Review Board: Susie Hoffman Leadership School of Medicine: Chris Kramer, Margaret Shupnik, Linda Duska Health System: Mike Marquardt Office of the VP Research: Dave Hudson University Organizational Development: Lee Baszczewski Project Manager: Olga Kipnis Operational Leadership: Thea Grover-Patrick, Sean Jackson, Paul Targonski Executives and Sponsors: Randy Canterbury, Richard Shannon, Pam Sutton-Wallace Data Information Steering Committee (DISC): Gretchen Arnold, Bo Cofield, Virginia Evans, Larry Fitzgerald, Jim Harrison, Brad Haws, Tracey Hoke, Rick Skinner, Glenn Wasson, Ken White

Leadership Project Manager: Olga Kipnis MS Operational Leadership: Thea Grover-Patrick MBA; Sean Jackson DMA; Paul Targonski MD, PhD Executives and Sponsors: Randy Canterbury MD; Richard Shannon MD; Pam Sutton-Wallace MPH Data Information Steering Committee DISC (individuals not listed in other roles): Gretchen Arnold MLS; Bo Cofield DrPH; Virginia Evans MS; Larry Fitzgerald CPA; Jim Harrison MD, PhD; Brad Haws MBA; Tracey Hoke MD; Rick Skinner MHA, MS; Glenn Wasson MS, PhD; Ken White MS, PhD

Workgroup Departments/Centers: Cricket Birks RN, CCRN; Sandra Burks RN, BSN, CCRC; Johanna Loomba BS; Goga Radakovic MD; Cathy Reniere MA Clinical Trials Office: Lori Elder RN, BSN, CCRA Office of Grants and Contracts: Stewart Craig MS; Lynn Koplin MA Institutional Review Board: Susie Hoffman RN

Advisory Departments/Centers: Amy Fansler MPH; Leisa Gonnella MHA; Bridget Graves PhD; Dina Halme PhD; Stacy Thompson RN; Jonathon Neel MS Principal Investigators: Patrick Dillon MD; Nathan Fountain MD; David Kaufman MD; Michael Salerno MD, PhD; Ron Turner MD Sponsor representation: Bob Meyer MD Clinical Trials Office: Amy Camblos BS; Jennifer Crosby BS, CCRP; Kathy Richardson BA, CCRC Institutional Review Board: Richard Stevenson MD Investigational Drug Services: Amy Adams PharmD, CCRP; Lauren Benusa PharmD Billing: UPG - Chris Allison; SOM - Angela Sherman BA

Stakeholders School of Medicine: Chris Kramer MD; Margaret Shupnik PhD; Linda Duska MD Health System: Mike Marquardt MBA, MPH Office of the VP Research: Dave Hudson PhD University Organizational Excellence: Lee Baszczewski BA, PMP

Commitments & Communication Project Manager: my commitments Workgroup: weekly contribution Advisory: guidance and contribution on as needed basis Operational Leadership: support and bi-weekly updates Executives and Sponsors: approval for direction and support as needed, monthly updates Stakeholders: guidance and updates as needed Clinical Research Process Improvement Project website: bi-weekly updates, opportunity to provide feedback, certain areas open for public Project documentation and communication

Implementation Plan (when) Lean Training By February 13 with Elliott Weiss and RCF Associates Value Stream Analysis with RCF Associates By March 6 Starting in April 90 day Projects Team Building; A3, Baseline, and Critical Success Factors By March 27

What to expect

Thank You!