Director, Asia Pacific Japan and U.S. Clinical Operations

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Presentation transcript:

Director, Asia Pacific Japan and U.S. Clinical Operations Building Synergy Between US and Japan: DES Clinical Trial Designs – Industry View Gary Thompson Director, Asia Pacific Japan and U.S. Clinical Operations Abbott Vascular

What is synergy? A synergy is where different entities cooperate advantageously for a final outcome. Simply defined, it means that the effect of the whole is greater than the sum of the effects of the individual parts. en.wikipedia.org/wiki/Synergy

Building Synergy 1992 - 2010 Global Harmonization Task Force Working Towards Harmonization in Medical Device Regulation The Global Harmonization Task Force was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. This is being done with two aims in mind: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world. http://www.ghtf.org/ - Welcome to the GHTF Website

Building Synergy cont. Harmonization By Doing The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD will utilize parallel development, application submissions and review of actual medical device projects by FDA and MHLW-PMDA in conjunction with the above-named constituencies. The objective is to eliminate redundancies, added costs, and time delays inherent in sequential trials. The intent of HBD is not simply to create guidance and discuss policy but to develop common protocols for investigational clinical studies that would allow safe and effective "breakthrough" cardiovascular technologies to benefit patients worldwide. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/InternationalInformation/ucm053067.htm

Building Synergies cont. Pre-IDE Process Informal Guidance Meetings Formal Guidance Meetings Pre-IDE Submissions Clinical Trial Consultations Pre-consultations Formal Consultations

Building Synergies cont. ANNOUNCEMENT (June 23, 2009): U.S. – Japan Pilot Program Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications The goal of the pilot program is to improve both the speed and quality of the consultation and review stages, allowing for potential earlier market access and an increased benefit to public health. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/InternationalInformation/ucm053067.htm

Structure of SPIRIT III Data on file at Abbott Vascular © 2010 Abbott Laboratories.

Structure of SPIRIT III Data on file at Abbott Vascular © 2010 Abbott Laboratories.

Trial Design Ideas Global Trial - Single Protocol Multiple countries (including Japan & U.S.) Meeting country specific requirements Two Country Trial (Japan & U.S.) – Single Protocol Country Specific Trials – Two Protocols Possibility of pooling data

Panel Question Are we seeing a synergy between the U.S. and Japan that will provide earlier market access to breakthrough technologies resulting in an increased benefit to public health? If so, what is the evidence?

Thank you