GI Coordinated Registry Network: A Case for Obesity Devices

 

Morning session: https://collaboration.fda.gov/p6eeqmva8x3/

After lunch: https://collaboration.fda.gov/p16jfzvl33t/

After afternoon break: https://collaboration.fda.gov/p4q5dpopces/

AGENDA

8:30-9:00Breakfast9:00-9:05Welcome and Introductions

Deborah Fisher (Duke), Tony Du (FDA)

9:05-10:20Stakeholder Perspectives

Moderator:  Ben Fisher (FDA)

Speakers/Affiliations9:05-9:15Use of Real World Evidence in Regulatory DecisionsOwen Faris (FDA)9:15-9:25Clinically Meaningful Outcomes for Weight Loss Procedures and DevicesMarina Kurian (SAGES)9:25-9:35Challenges in Generating Evidence for Obesity TherapiesLaura Eaton (Apollo)9:35-9:45Patient Perspective: Meaningful Weight Loss and Associated Tolerance for RiskJoseph Nadglowski (OAC)9:45-10:05Moderated Talk and Q&A Session:

§  What are the Benefits of Registry Data in Regulatory Decision Making: A Case for Collaboration

§  Medical Product Development in the Obesity Space

§  Recent Approvals (gives background and helps to make the case for better data and possibly smaller PAS studies), Opportunity to Standardize Collection of Data

Speakers/Moderators:

Cynthia Long (FDA), Jeff Cooper (FDA)

10:05-10:20DiscussionAll Above as Panelists10:20-11:45Capitalizing on National Data Infrastructure

Moderator:  Kathy Crothall (Aspire Bariatrics)

10:20-10:30Existing Registry LandscapePankaj Jay Pasricha (AGA)10:30-10:40Strategic Priorities and Strategically Coordinated Registry Networks: Foundations of the Medical Device EcosystemDanica Marinac-Dabic (FDA)10:40-10:45Partnering with Patients Strategic PriorityMartin Ho (FDA)10:45-10:55A Perspective on MedicareLouis Jacques (ADVI)10:55-11:05Experience in Registry DevelopmentRobin Scamuffa (Ethicon Endo-Surgery)11:05-11:15Governance and Sustainability ModelsMitchell Krucoff (Duke)11:15-11:25The MBSAQIP Database: PROs, Post Market Surveillance and Performance Metrics (QCDR)Matthew Hutter (ASMBS)11:25-11:45Panel Discussion:

Existing/National Standards for Interoperability, UDI, Claims Data, and Methodological Opportunities

Lisa Lang (NLB), Julia Skapik (ONC), Leslie Steen (FDA), Behnaz Minaei (FDA), TBA (Sentinel), Laura Hatfield (Harvard), Barry Greene (ASMBS)11:45-12:00Charge to Working Groups

Deborah Fisher (Duke)

See Below – Groups 1, 2 and 312:00-12:45Lunch13:00-14:30Small Group DiscussionsGroup 1:  Clinical issues

§  Exposure (implantation of device) and outcomes

§  Clinical questions/gaps (technology vs. disease)

§  Minimum core datasets (pre- and post-market endpoints)

§  Data dictionary, collection method/form, agreed upon endpoints/elements

§  Follow-up requirements and possibilities for and issues with longer-term follow-up

Chair:  Cynthia Long (FDA)

Rapporteur:  Barry Greene (ASMBS)

Group 2: PROs

§  Existing PROs, gaps needing validation – and developing the endpoints, means of capturing in registry (via mobile app)

§  Patient protection

Co-chairs:  Martin Ho (FDA), Karen Ulisney (FDA)

Rapporteur:  Suzanne Schrandt (PCORI)

Group 3: Data quality by design, Data sources

§  Data quality, standardization, integration

§  Linkage between clinical and informatics (CMS etc.)

§  Registry, electronic health record, UDI

Co-chairs:  Deborah Fisher (Duke), Irfan Khan (FDA)

Rapporteur:  Leslie Steen (FDA),  Behnaz Minaei (FDA)

14:30-14:45Break 14:45-16:00Report Out of Work Group Decisions

Moderator:  Deborah Fisher (Duke)

14:45-15:15Group 1, 2 and 3 report out (10 minutes each)15:15-15:30Select first project for development15:30-15:45Define requirements for registry participation15:45-16:00Define mechanism for data sharing16:00-16:30Directions and Action Items

Ben Fisher (FDA) and Danica Marinac-Dabic (FDA)