Building a Statewide Cancer Clinical Trials Network September 25, 2018 Marie L. Rahne, MBA Senior Manager, Minnesota Cancer Clinical Trials Network
7 & 19 Partners Sites 59 Minnesotans Enrolled on Cancer Clinical Trials 18 Trials Enrolling Patients
Mission Statement The Minnesota Cancer Clinical Trials Network (MNCCTN) aims to improve cancer outcomes for all Minnesotans through greater access to cancer clinical trials in prevention and treatment.
Today s Objectives I. The conditions and needs that led to the development of a statewide clinical trials network in Minnesota II. Identify key steps to building and implementing a statewide clinical trials network III. Discuss lessons learned from the first year
I. What Led to the MNCCTN?
Cancer Burden in Minnesota Nearly 50% of all Minnesotans will be diagnosed with a potentially life-threatening cancer during their lifetimes 25% of Minnesotans die of cancer Cancer is the #1 cause of death in our state Lung cancer is the #1 cause of cancer deaths for both men and women, followed by colorectal cancer
Access to Clinical Trials 42% of Minnesota s population lives outside the twin-cities metro area (UMN) and greater Rochester area (Mayo Clinic) #1 reason that a clinical trial fails unable to meet enrollment needed How do we increase ACCESS? Access TO patients and access BY patients?
Masonic Cancer Center, University of Minnesota Increase participation in research that addresses the cancer burden of the people of Minnesota
MnDRIVE Partnership between UMN and State of Minnesota -- Areas of research strength + Minnesota s key and emerging industries Focus on addressing grand challenges 2013 with $18 million Robotics, Global Food, Environment, Brain Conditions 2017 call for ideas
The Pitch J. Brooks Jackson, MD, MBA Formerly, VP for Academic Health Center, UMN Currently, VP for Medical Affairs and Dean of the Carver College of Medicine, Univ. Iowa Expand access to cancer clinical trials in Greater MN Recognized momentum around cancer research Biden Moonshot and federal funding Nearly everyone knows someone impacted by cancer
Creating the Request to the Legislature Masonic Cancer Center took the lead Describing cancer burden and importance of clinical trials Emphasis on benefit to rural populations Momentum around cancer research Approval at all levels of the University 4 requests were brought forth and approved by Regents of UMN to go to the legislature
Advocacy at the Capitol 5 months UMN Alumni UMN Alumni Association 10K alumni contacted their legislators in support AHC/Medical School & Masonic Cancer Center Storm the Capitol via Twitter cancer stats and information, highlighted UMN research. Leadership testifying at Capitol Open house at Capitol. Wellprepared and organized. Allies ACS CAN letters of support and awareness Mayo Clinic and Medical Alley letters of support
Keys to Funding Success Governor s support Included in Governor's budget Focus on Greater MN Buy-in of representatives and senators Alignment of momentum Moonshot and federal focus on cancer research Advocacy and support of partners Allies and alumni Past successes of MnDRIVE initiative
Result $4 million recurring, annually in the state budget for access to cancer clinical trials.
II. Building and Implementation
Preparation Defining the MNCCTN Defining WHAT MNCCTN would be Grounded in the intent of the funders access for rural populations Identifying partners Must have clinical research experience Must serve the residents of MN Assist with the HOW of MNCCTN
Preparation Consulting with other state-wide networks Contract examples and advice Establishing administrative hub Job descriptions for Senior Administrative Leader and Medical Director Website, logo, branding Drafting master agreement between partners Understanding legal implications and options
Green Light Convened Steering Committee Spend the money Establish Administrative HUB Hired Senior Administrative Leader and Medical Director Distribute money to initiate research at new sites Asked our partners via RFP
RFP Issued to potential partners Serve MN residents and had experience with clinical research Site requirements Offered no prior access to cancer clinical trials or have limited access Enrolled fewer than 12 patients annually Located outside 7-county metro area and Rochester (30 mile radius) Up to $500K annually per partner
MNCCTN s Focus Provides funding for infrastructure at sites so they are able to offer cancer clinical trials Staffing, equipment, community engagement, etc. Not intended to fund specific studies Emphasis on investigator-initiated trials Masonic Cancer Center, Mayo Clinic Cancer Center, and Hormel Institute Interventional trials Trials that are designed to have an interventional follow-up
MNCCTN Sites Essentia Health Mayo Clinic Cancer Center Sanford Health Fairview Health Metro-MN Comm. Oncology Research Consortium Native American Community Aitkin Deer River Detroit Lakes Fosston Virginia Hibbing Park Rapids +8 Austin Albert Lea Mankato Worthington Thief River Falls Hibbing Grand Rapids Princeton Hastings Cambridge Monticello Central Minnesota 19 sites in 2018, with 8+ to be added by 2020.
Initial Implementation Work Negotiation Execution Master Agreement Personnel HUB Staff Partner and Site Staff Press Release Community Buy-in Marketing Clinical Trials Select Initial Trials Additional Programs
MNCCTN Trials Cooperative Group and Other Trials ACCESS and CAPACITY BUILDING Investigator-initiated Interventional or leading to interventional follow-up Available to any site within MNCCTN Screening and prevention Partner NCI Community Oncology Research Program members SWOG, Alliance, NRG, etc. ACCRU Members Internal investigator-initiated trials
Keys to Implementation Success Built relationships Understanding strengths and concerns of partners and sites Partnership of equals Stayed true to the focus access for Greater MN Communicated constantly with partner and funders - UMN/legislature Celebrating milestones and wins Progress will be slow. Need to maintain momentum, excitement and attention Website launch, first trial identified, staff hired, patients enrolled, etc.
III. Lessons Learned
Successes 59 18 19 60 10 Minnesotans enrolled since inception. Trials open. Cooperative group and investigator initiated. Sites in 2018. 8 sites enrolling, 11 enrolling soon. 29 by 2020. Personnel actively working on MNCCTN across the state. Trials in the pipeline. *as of July 31, 2018
Other Successes Implementation of single CTMS across all sites Statewide joint press release after all contracts executed Staffing at HUB and Medical Director in place Staffing at partners and sites First round of quarterly reporting completed Partner visits Contracting completed and funding set-up at UMN Intranet website for internal communications and documents
Key Factors in Successes Dedicated staff at UMN Bring MNCCTN into UMN s systems, processes, and policies Understand how MNCCTN fits into each of partners Recognizing partner s strengths and letting them lead Building trust and relationships Consistent communication to all stakeholders Two way communication Focus on the mission
Challenges Expectations of Immediate Results Funding job done Recognizing and celebrating incremental progress Legal structure Single entity vs. partnership vs. other Dives how decision are made
Challenges Institutional Review Board Central IRB? Costs for commercial IRB, timelines, efficiency and effort Retrofitting trials to run through the network Connecting with investigators before they have a final protocol Standardizing SOPs between partners Offering resources available at UMN but allowing partners to use what they have in place Clinical partners with varying capacities (partner and site level)
Next Steps Strategic plan 5 year plan in place by summer 2019 Quality assurance Monitoring, data management, overall quality assurance Site visits Building relationships with site personnel Open trials Learning and refining from each experience
MNCCTN Goals 3 to 4 MNCCTN trials open in 2018, 5 to 7 in 2019 12 participants per partner in year 1, 30 in year 2 Strategic plan in place Second RFP Fully staffed at HUB, partners, and sites 10 trials in years 3 to 5, 15+ in years 5 and beyond 500 patients overall by 2022, 250 on II trials Open a trial brought forth by a community provider Statewide clinical trial database Leveraging additional funding
Marie L. Rahne mrahne@umn.edu mncancertrials.umn.edu