CTSA Trial Innovation Network Early Vision & Goals MONICA SHAH, MD DIRECTOR, TRIAL INNOVATION NETWORK

CTSA Trial Innovation Network Early Vision & Goals MONICA SHAH, MD DIRECTOR, TRIAL INNOVATION NETWORK

What Do They Have in Common? Hammer M. Harvard Business Review, 2004.

What Do They Have in Common? Operational Innovation Inventing and deploying new ways of doing work Hammer M. Harvard Business Review, 2004.

Clinical Trials Opportunity for Operational Innovation Califf RM et al. JAMA 2012; Hirsch BR et al. JAMA Intern Med 2013; Goswami ND et al. PLOS One 2013; Alexander KP et al. JAHA 2013;Todd JL et al. Annals ATS 2013; Inrig JK et al. Am J Kidney Dis 2014

Clinical Trials Opportunity for Operational Innovation Results of Current Work Models Small, single-center studies Variations in rigor Poor enrollment Decreased scientific impact Operational Challenges Parallel research universe Fragmented infrastructure Huge budgets, misaligned incentives Lack of collaborative efforts Califf RM et al. JAMA 2012; Hirsch BR et al. JAMA Intern Med 2013; Goswami ND et al. PLOS One 2013; Alexander KP et al. JAHA 2013;Todd JL et al. Annals ATS 2013; Inrig JK et al. Am J Kidney Dis 2014

Clinical Trials Opportunity for Operational Innovation Results of Current Work Models Opportunity for Operational Innovation Small, single-center studies Variations in rigor Poor enrollment Decreased scientific impact Invent & deploy new Operational Challenges approaches Parallel research universe to clinical trials Fragmented infrastructure Huge budgets, misaligned incentives Lack of collaborative efforts Califf RM et al. JAMA 2012; Hirsch BR et al. JAMA Intern Med 2013; Goswami ND et al. PLOS One 2013; Alexander KP et al. JAHA 2013;Todd JL et al. Annals ATS 2013; Inrig JK et al. Am J Kidney Dis 2014

NIH Clinical Trials Opportunity for Operational Excellence NIH Budget FY 2015 $3.2 B ~10% Clinical Trials $27.1 B NIH Budget Office; Mullard A. Nature Reviews Drug Disc 2016; GAO Report, 2016; Innovation for Healthier Americans, 2015

NIH Clinical Trials Opportunity for Operational Excellence NIH Budget FY 2015 Results of Current Work Models $3.2 B ~10% Clinical Trials Large unobligated balances Trials not finishing on time or within budget Decreased return on research investments Decreased public trust $27.1 B Operational Challenge Enhance stewardship & accountability of NIH clinical trials NIH Budget Office; Mullard A. Nature Reviews Drug Disc 2016; GAO Report, 2016; Innovation for Healthier Americans, 2015

NIH Clinical Trials Opportunity for Operational Excellence NIH Budget FY 2015 Results of Current Work Models $3.2 B ~10% $27.1 B Opportunity for Clinical Trials Large unobligated balances Trials Operational not finishing on Excellence time or within budget Decreased return on research investments Execute trials Decreased public better, trust faster, & more Operational Challenge cost-effectively Enhance stewardship & accountability of NIH clinical trials NIH Budget Office; Mullard A. Nature Reviews Drug Disc 2016; GAO Report, 2016; Innovation for Healthier Americans, 2015

Imagine A Clinical Trials Superhighway A Network that Accelerates the Translation of Novel Interventions to Evidence Based Treatments Single IRB Reliance Model Master Contracts Harmonized Data Collection Streamlined Protocols Poised Research Teams Patient Engagement

Trial Innovation Network Mission Leverage, in an unprecedented way, the talent, expertise, & resources of the CTSA Program to transform clinical trials Collaborative national Network Accelerate planning & implementation of high quality multi-center trials & studies Provide more treatments to more patients Improve public health Create a national laboratory to study, understand, and improve multi-center clinical trials

Trial Innovation Network What Is It? CTSA Hubs Partners NIH ICs Federal Non-federal Network Center Collaborative Strategic Management Partners Patients Trial Innovation Centers (TICs) NCATS & Network Exec. Comm. & CTSA Recruitment Innovation Centers (RICs)

Partnership Scientific Questions Supported By: NIH Institutes Industry Other Partners Trial Innovation Network How Will It Work? Operational Excellence Doing Trials Better, Faster, & More Cost- Efficiently Trial Innovation Network Results New Science Studies that Finish on Time & within Budget Generate Evidence to Change Clinical Practice Early Protocols CTSA Hubs RICS NCATS TICS Robust Clinical Trials Operational Questions Supported By: NCATS Operational Innovation Testing New Approaches to Clinical Trials Recruitment, Contracts, IRB, Other Results New Operational Approaches Generate Evidence to Change Research Practice

Trial Innovation Network Key Elements Infrastructure Elements o Single IRB Reliance Model SMART IRB Model o Strong Business Models Master contracts Streamlined budgeting Clear workflows o Streamlined Protocols Master protocol & CRF templates Common data elements Protocol review committee o Poised Research Teams Standardized site training o Harmonization Informatics Collaboration Elements o Clear Organization Structure supports collaboration & early engagement o Clear Communication Regular meetings to share and discuss plans with key partners Trial Innovation Network Website o Foster Relationships Teams that focus on collaboration with CTSA Hubs, NIH Institutes, Patients, Other Partners o Evidence Based Learning & Improvement Performance Metrics o Dissemination Plan Focus on engagement & impact Publications & data sharing

Trial Innovation Network Leveraging Operational Innovations from the CTSA Program Master Contracts SMART IRB Reliance Platform Standards for Competencies & Training in Clinical Trials EHR Based Recruitment

Trial Innovation Network What Is the Added Value? For Investigators One-stop shopping to implement clinical trials TICS & RICS expertise in operational innovation & operational excellence CTSA Hubs broad expertise; large, diverse patient populations More competitive clinical trials applications for NIH ICs For NIH Institutes and Industry Partners Trials completed on time and within budget Shared NIH mission to innovate & transform clinical trials & optimize stewardship

Trial Innovation Network Timeline Collaborative Strategic Planning & Management First 6 Months May NCATS Council June Awards Released Develop Network Strategic Plan Launch Demonstration studies Year 1 Demonstrate & disseminate key elements of superhighway Year 2 Launch large scale clinical trials Operationalize SMART IRB Model, Master Contracts, Workflows, Other Strategic Priorities in Demonstration Studies

Trial Innovation Network Demonstration Studies To be implemented immediately Small clinical trials & studies (n ~200) testing simple, low-risk interventions Ideal candidates R01 clinical trial applications Reviewed but pending funding decisions Early stage investigators Feasibility analysis of entry criteria

Trial Innovation Network NCATS Team Name Monica Shah Michelle Culp Todd Wilson Mary Purucker Ken Gersing Kat Schwartz Patricia Jones Tiina Urv Stacia Fleisher Redonna Chandler Petra Kaufmann Role Director, Trial Innovation Network Director, Clinical Operations Program Officer Director, CTSA Hub Program Director, Biomedical Informatics Program Analyst, Trial Innovation Network Program Officer Program Officer Deputy Director, Office of Grants Management Deputy Director, DCI Director, DCI

Trial Innovation Network The Future Collaboration key to transform the clinical trials enterprise & optimize stewardship Trial Innovation Network Operational Excellence & Operational Innovation Resource for scientific community & NIH NCATS welcomes your input, engagement, & partnership as we develop the Trial Innovation Network Program Contacts Monica.Shah@nih.gov Petra.Kaufmann@nih.gov

Trial Innovation Network A Historic Opportunity to Accelerate Translation Through Operational Innovation, Operational Excellence & Collaboration