Early Feasibility Studies (EFS) in the U.S. with a Focus on Valvular Heart Disease: Updates, Impact and Future Directions. Chip Hance June 16 th 2017
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1 Early Feasibility Studies (EFS) in the U.S. with a Focus on Valvular Heart Disease: Updates, Impact and Future Directions Chip Hance June 16 th 2017
2 Disclosure Statement of Financial Interest I, Robert Hance, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. All TVT 2017 faculty disclosures are listed online and on the app. All TVT 2016 faculty disclosures are listed online and on the app.
3 MDIC: Medical Device Innovation Consortium Disclosure Statement of Financial Interest A Public-private Partnership Created to Advance Medical Device Regulatory Science for Patient Benefit. Members (n=60) Public: FDA, CMS, NIH Private: Large and Small Manufacturers Not-For-Profit: Patient organizations MDIC Established 2012 Bill Murray, CEO Offices: Washington DC and Minneapolis All TVT 2017 faculty disclosures are listed online and on the app.
4 MDIC: A Sample of Ongoing Initiatives NEST: National Evaluation System for Health Technology Virtual Patient : Use of virtual patients to reduce clinical study sample size Private Payers: Piloting involvement of payers in pivotal study design EFS Administrative and Clinical Practice Improvements
5 FDA: Early Feasibility Studies Program Objectives Earliest Patient Access: Potentially beneficial medical devices in the U.S. U.S. Leadership: Maintain or regain leadership in medical device innovation Encourage Close Collaboration: Between developers & users Clinical Study Continuity: Early clinical use, Pivotal studies, U.S. approval, Post-approval FDA s Leadership Has Allowed U.S. Sites to Reengage in Early Clinical Research Andrew Farb, MD and Dorothy Abel, FDA, CDRH, ODE Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies
6 EFS Program: Up and Running Guidance Established in 2013 FY2015/2016/2017 EFS Participant Data 39 EFS submissions to-date in FY2017 (50+ expected)
7 Growing Interest: EFS Process Efficiency Source: Journal of the American College of Cardiology, October 25, 2016 Newly Formed Executive Committee David Holmes (Chair/Mayo) Karen Alexander (Duke) Dan Burkoff (CRF) Joseph Chin (CMS) Chip Hance (MDIC/Industry) Aaron V. Kaplan (Dartmouth) Martin Leon (CRF/Columbia) Michael Mack (Baylor) Jeff Shuren (CDRH/FDA) Tamara Syrek-Jensen (CMS) Bram Zuckerman (CDRH/FDA)
8 MDIC-EFS Working Group: Administrative and Clinical Practices Co-Chairs: Andrew Farb (CDRH/FDA) Chip Hance (MDIC/Industry) Aaron V. Kaplan (Dartmouth) Focus Areas: I. FDA/Sponsor: IDE Approval II. Site Ethics (IRB) Approval Program Management: Shawn Ahmad (Dartmouth) Dan Schwartz (MDIC) Jing Xie (MDIC) Jamie Walkowiak (Baylor) III. Site Contracting IV. Site Patient Recruitment 16 Industry Contributors
9 No. of Studies I. FDA: IDE Approval Results from Identified Structural Heart Studies 3 Time for IDE Protocol Approval 3 Structural Heart Studies: < 30 days days days days >120 days Average IDE Approval Time = 38 days Close Sponsor-Investigator-FDA Collaboration Source: MDIC Survey of EFS Structural Heart Sponsor Participants Results as of 6/9/2017
10 No of Sites II. Ethics (IRB) Approval Results from Identified Structural Heart Studies Time for IRB Approval Structural Heart Studies: 6 Sites: < 30 days days days days days > 180 days ~2/3 of Approvals Within 60 Days Results May Reflect IRB Submission Following Contract Approval Source: MDIC Survey of EFS Structural Heart Sponsor Participants Results as of 6/9/2017
11 No of Sites III. Site Contracting Agreement Results from Identified Structural Heart Studies Time for Contract Sign-off Structural Heart Studies: 6 Sites: < 30 days days days days days > 180 days Biggest Roadblock Site/Sponsor Site Indemnification Problematic Source: MDIC Survey of EFS Structural Heart Sponsor Participants Results as of 6/9/2017
12 No of Sites IV Patient Recruitment Results from Identified Structural Heart Studies Time from IRB Approval/Contract Sign-off to 1st Enrollment 11 Structural Heart Studies: 6 Sites: < 30 days days days days days > 180 days *Represents 28 of 38 participating sites with complete reported data. Variability Possibly Reflects Differences in: Protocol/Patient Population Investigator Training & Proctoring Source: MDIC Survey of EFS Structural Heart Sponsor Participants Results as of 6/9/2017
13 Conclusions: Early Feasibility Testing in the US FDA Changes Enable (IDE) Early Feasibility Studies in the U.S. Companies Have Embraced FDA s New Pathway Structural Heart/Valvular Studies in the U.S. Increasing MDIC-EFS Analysis Administrative Challenges Now the Largest Barrier, Especially Contracting Further Collective Efforts Required to Make U.S. Clinical Ecosystem Competitive
14 MDIC-EFS: Key Deliverables Build Data Bank & Performance Metrics Streamline Contracting Develop Template Language Site Operations: Share Best Practices Establish Site Network Sites Committed to Best Practices Your Help & Support Required Success Requires Sharing Anonymized Data Medical Device Companies (Big & Small) Clinical Sites
15 MDIC-EFS: Thank You Your Help & Support Required Chip Hance (MDIC Board Sponsor) Andrew Farb (FDA) Aaron Kaplan (Dartmouth)
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