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IMDRF Registry Working Group Update
Working Group Chair: Danica Marinac-Dabic, MD, PhD, FISPE
US FDA
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Highlights • Face to face meeting was held in Moscow, Russia,
December 2016 • IMDRF/Registry WG/N42: Essential Methodological
Principles in the Use of International Medical Device Registry Data document was finalized and submitted to IMDRF management committee for consideration
• Registry pilot projects concepts have been further developed and refined
• Real World Evidence used as context for registry • New Work Item Proposal (NWIP) submitted to IMDRF
management committee
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Face to Face Meeting • Objectives:
– Address any comments received during the public consultation process on the methodology document and finalize the document
– Discuss potential pilot projects – Discuss the use of Real World Evidence (RWE) -
extension of the registries essential principles to evaluate other data sources
– Discuss and develop a NWIP
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Pilot Projects • Example of candidate projects presented and discussed
with potential sponsors – Vascular, TAVR/SAVR, scoliosis treatments , flexible
knee • Discussed industry interest • Pilots should proceed independently from IMDRF Registry
WG - but the WG members will serve as regulatory champions on each pilot project
• Registry WG will develop metrics to assess impact of the essential principles document on efficiencies conducting each pilot
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NWIP – Purpose • To develop an:
– IMDRF Registry Qualification Tool – IMDRF Real-World Evidence essential
principles document and a catalogue of existing RWE efforts
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• Opportunity to converge regulatory use of RWD/RWE efforts in a broader context (registries, EHR, claims, etc.) – Developing IMDRF qualifying tool for registries and
other RWD sources for regulatory decision making will facilitate the convergence
– Creating a catalogue of existing international RWE efforts and principles documents for use of other data sources beyond registries will fill an important gap
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NWIP – Rationale
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Phased Approach • Phase 1
– Create a qualification tool for international registries taking into consideration a variety of regulatory decisions (e.g. clearance/approval, label extension, signal detection).
– The qualification tool will incorporate recommendations from the IMDRF registry principles documents to produce a practical qualification tool.
• Phase 2 – Develop principles for evaluation of the real world data
sources beyond registries. – This work is critical for regulatory convergence in evidence
generation and appraisal for those clinical areas where no registry/consortia or coordinated registry networks exist.
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Draft principles document: Spring 2017 Face-to-face meeting: June 2017 Proposed draft: July 2017 Management Council document review: September 2017 Comment period: October/November 2017 Face-to-face meeting, review & resolve comments: January 2017 Proposed final document submitted: February 2018
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Phase 1: Registry Qualification Tool Timeline
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Draft principles document: Spring 2018 Face-to-face meeting: June 2018 Proposed draft: July 2018 Management Council document review: September 2018 Comment period: October/November 2018 Face-to-face meeting, review & resolve comments: January 2019 Proposed final document submitted: February 2019
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Phase 2: RWE Essential Principles and Catalogue of RWE Efforts Timeline
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Thank You
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