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Evolving Importance of Post-Approval Studies

Published byPriscilla Harrington Modified over 6 years ago

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Presentation on theme: "Evolving Importance of Post-Approval Studies"— Presentation transcript:

1 Evolving Importance of Post-Approval Studies
Danica Marinac-Dabic, MD, PhD Director, Division of Epidemiology 1 1 1

2 Summary Public health context/need Recent CDRH Initiatives
Focus on innovative methods Focus on national/international infrastructure Focus on collaboration/partnership Vision for the future

3 TPLC Context TPLC begins with “on market” knowledge
Utilization/diffusion into clinical practice Patterns of use in different populations Long-term safety and effectiveness Benefit/risk profile in a “real world setting” Learning curve issues Heterogeneity of treatment effects Comparative safety and effectiveness Public health impact/burden

4 Postmarket Context MDEpiNet Sentinel Public Health Need Infrastructure
FDA - Mandated Postmarket Studies Sponsored Public Health Need Infrastructure Methods MDEpiNet Sentinel

5 Registries Initiative ICOR Initiative
Focus on Infrastructure: Registries Initiative ICOR Initiative

6 Ongoing Registry Efforts
Use existing registries for PAS studies and surveillance INTERMACS (NIH, CMS, FDA) Total Joint Replacement Registry (Kaiser) Australian National Joint Replacement Registry Facilitate new registry development Transcatheter Aortic Valve Replacement Registry (ACC/STS) Fibrillation Registry (ACC, HRS, STS) American Joint Replacement Registry (AAOS) Diagnostic and Therapeutic Bronhoscopy Registry (ACCP) Uro-Gynecological Mesh Registry IMPACT Registry (ACC) For exemple CDRH:

7 Ongoing Registry Efforts (cont)
Use existing registries for discretionary studies ICD Registry (ACC-NCDR) Adult Cardio-Thoracic Database (STS) Total Joint Replacement Registry (Kaiser) OUS Orthopedic Registries (Australia, Denmark) Explore registry capabilities Active surveillance: short-term and longitudinal (DELTA) Linkages studies with Medicare claims data Advocate for registries (AHRQ’s Guide on Registries) Build methodological infrastructure for registries (ICOR)

8 Evidence Synthesis Initiative
Focus on Methods: Evidence Synthesis Initiative

9 Innovative Methods Make better use of existing pre & post approval data Integrate/combine when appropriate! Use Simultaneous: Meta-analysis Network meta-analysis Cross-design synthesis Bayes factors Methods of Data Integration Direct measure of evidence

10 Focus on Strategic Partnerships:
MDEpiNet Initiative

11 MDEpiNet Initiative To develop infrastructure and innovative methodological approaches for conducting robust studies to improve medical device safety and effectiveness understanding throughout the device life cycle through Public Private Partnership with academia and other stakeholders . MISSION Read

12 MDEpiNet Academic Institutions
Harvard University (Methodology Center) Cornell University (Science and Infrastructure Center) University of North Carolina Duke University University of Alabama University of Washington Vanderbilt University University of Southern California University of Oxford

13 Impact - Vision for the Future
Improved knowledge of extent of observational clinical data available for regulatory decision making inventory and evaluate data sources, to leverage existing clinical data for premarket submissions use data sources and infrastructure to evaluate signals that are raised, thus decreasing the need for additional de novo studies in the postmarket setting and providing an evidentiary basis for next generation device development identify additional needs for infrastructure and methodologies for device performance evaluation

14 Impact – Vision for the Future (cont)
Reduced burden on industry reduce burden on each sponsor to develop own infrastructure for premarket clinical studies and mandated postmarket studies and surveillance eliminate the need for multiple costly studies being independently developed by several sponsors for similar devices with knowledge of all worldwide data/infrastructure, all manufacturers will benefit because evidence can be used to inform next generation of medical devices Pan –stakeholder input through Public Private Partnership all medical device stakeholders represented for decision-making process

15 Example: TVT Registry

16 Thank you! (301) ‏

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