Overview of HBD Activity 2003-2019
Transcript of Overview of HBD Activity 2003-2019
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Overview of HBD Activity
2003-2019
Mitchell W. Krucoff, MD, FACC, FAHA, FSCAIProfessor, Medicine/Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Duke Clinical Research Institute
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HBDProgram History
Uchida T et al, Circulation Journal 2013
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September 2003
The Era of Global Regulatory Harmonization
David Feigal MD
Director, CDRH 1999-2004
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December 2003
http://www.fda.gov/cdrh/international.html
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2003-2004: Japan MHLW launches PMDA
April 2004:
PMDA Adopts Early
Consultation
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HBD Foundational Principles
1) Balanced stakeholder leadership/participation
2) Pre-competitive collaboration, dialogue & trust
3) “Small steps to big changes”
4) Emphasis on “doing” (POC projects &
deliverables)
5) Barrier elimination supporting global regulatory
harmonization pathways
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HBD
Proof Of Concept (POC) Projects
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HBD POC’s
Educational Programs & Thinktanks
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Japan Circulatory Society
March 2004
Tokyo, Japan
TCT, CRT, ACC,
CVIT, CCT, JCS, CIT,
Sing Live, RAPS,
JFMDA, Advamed,
CSRC, EuroPCR
2004-2019:
From “Japan-USA Barriers”
to “Japan-USA Synergies”
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December 2004: Kamakura Public Forum
Attention to the Patient’s Perspective
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Medical Technology Leadership Forum
Washington D.C.
April 2005
Hiroshi Yamamoto
MHLW
Dan Schultz
U.S. FDA
Mitch Krucoff
Duke/DCRI
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Tomiko Tawaragi
MHLW
October 2007
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HBD POC’s
Harmonized Regulatory Processes
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Regulatory Convergence:
Ethics, Methods and Science of Human Studies
Regulatory Focus, April 2010
Regulatory Focus, January 2013
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HBD POC’s
Post-market Surveillance Registries
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Linking Post-Market Surveillance: LVADS
JMACS
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HBD POC’s
Global Clinical Trials
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2005: Endeavor Japan (Medtronic)
• Identical inclusion/exclusion
• Identical endpoints
• Identical core laboratories
• Enhanced poolability
• Enhanced interpretability
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2007: SPIRIT III Japan (Abbott Vascular):
Enhanced poolability & interpretability
• Concomitant enrollment
• Identical inclusion/exclusion
• Identical endpoints
• Identical core laboratories
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2009: Zilver PTX (Cook Medical)
Single protocol global RCT
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21
HARMONEE Study: Coronary DES Japan-USA RCT
Kong DF et al Am Heart J 2017;187:112-121
Saito S, Krucoff MW et al. European Heart Journal (2018) 0, 1–9 doi:10.1093/eurheartj/ehy275
The COMBO Plus Dual Therapy Stent
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COAST Study (CSI)
To evaluate the performance of the Coronary OAS Micro Crown in treating de novo, severely calcified coronary lesions Prospective, single-arm, multi-center Investigational Device Exemption (IDE)
study conducted in Japan and the USA
Harmonization by Doing (regulatory collaboration between Japan and the USA)
*6 subjects died and 1 subject lost to follow-up
1-year follow-up completed* (93/100)
74 patients12 sites
100 patients enrolled
26 patients5 sites
USA Japan
14
Diamondback 360® Coronary OAS Micro Crown
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HBD POC’s
Present Into Future Directions
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HBD
“Harmonization By Data”:
• Consensus definitions
• Minimum core data sets
• Data quality
• Data structure & interoperability
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The Academic Research Consortium (ARC):
Pragmatic consensus definitions for device evaluation
• Coronary
• Bleeding
• Aortic valve
• Mitral valve
• Neurologic
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Societies
ACC
SCAI
ESC
ISCTR
Patel MR et al, JACC 2015: 65:931-41
Peripheral ARC (PARC)
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Defining high bleeding risk in patients undergoing PCI
A consensus from the Academic Research Consortium for High Bleeding Risk
Philip Urban, Roxana Mehran,
Marie-Claude Morice and Mitchell Krucoff
on behalf of the ARC-HBR group
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Real World Evidence:Data Structure, Quality & Capture
Coordinated Registry Networks (CRNs) & NEST
Krucoff MW, Normand SL et al, JAMA 2015JAMA Published online July 11, 2016
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https://nestcc.org/demo-announcement/
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Registry Assessment of Peripheral
Interventional Devices (RAPID):
Core Minimum Data Set for Device Evaluation
Jack L. Cronenwett, M.D.
Dartmouth-Hitchcock Medical Center
Pablo Morales, M.D.
U.S. FDA
Robert Thatcher
CEO 4C Medical
Mitchell W. Krucoff, M.D.
Duke University Medical Center/Duke Clinical Research Institute
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RAPID Minimum Core Elements for PAD Devices:
Trans-Pacific Co-publication
Jones WS, Krucoff MW et al, Circ J 2018: 82:316-22 Jones WS, Krucoff MW et al, J Vasc Surg 2018: 67:637-45
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Late Mortality Safety Signal Discernment for
Paclitaxel Delivery Devices in PAD
https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-
coated-balloons-and-paclitaxel
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RAPID PTX Pathways Program
Lean CRF
SMART CRF
Patient Preference Science
Signal Discernment
Biostatistics & Epi
Independent Programs &
Projects
FDA PTX Team
Industry collaborative
Professional societies
collaborative
Working Groups Partner Collaborations
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September 2013
Hess C et al, Am Heart J 2013
Rao S et al JACC Cardiovascular Int 7(8)2014
Lauer M et al, NEJM 2013
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IMDRF Essential Principles for Device Evidence:
Registry Infrastructure and Analytic Methodologies
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-180327-usability-tools-n46.pdf
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-methodological-principles.pdf
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European Heart Journal (2019) 40, 2745–2759
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Cardiogenic Shock Devices
Samsky M, Krucoff M et al Am Heart J November 2019
Shock III at CRT
Saturday Feb 22, 2020
Washington D.C.
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HB Doing
Early Feasibility Studies (EFS)
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Early Feasibility Studies: Can We Do Together?
2013-2017-2019
https://www.fda.gov/downloads/MedicalDevices/DeviceReg
ulationandGuidance/GuidanceDocuments/ucm279103.pdf
Percutaneous Mitral Valve EFS POC
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HB Doing
HBD for Children
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POC candidatesCovered CP Stent
Medtronic Melody Transcatheter Pulmonary
ValveAMPLATZER muscular VSD occluder
industry NuMED Medtronic ST.JUDE MEDICAL
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Future directions
International approaches to safety signal
discernment PTX in PAD
Real World Evidence
HBD for Children
Early Feasibility Studies: mitral valve
High Bleeding Risk PCI patients
Multi-national collaboration: Inter2Nest
Vascular shunts
Billing data for event ascertainment ?
Cardiogenic shock ?
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HBD
Together We Have Made a Pretty Big Splash!