Medical Devices
FDA Workshop: Methodologies for Post-Approval Studies of Medical Devices, September 9-10, 2009
Date, Time and Location
The meeting will be held on September 9, 2009 from 9:00 a.m. to 5 p.m. and September 10, 2009 from 9:00 a.m. to 4 p.m. at the following location:
Food and Drug Administration
Building 2, Room 2031
10903 New Hampshire Ave.
Silver Spring, MD 20993
* Please allow sufficient time for security screening.
Agenda
Day 1 (September 9)
| 8:00 am | Breakfast and Registration |
| 9:00 am | Welcome |
| 9:00 am | Jeff Shuren, MD, JD, Director, CDRH |
| 9:10 am | Susan Gardner, PhD, Director, CDRH/OSB |
| 9:20 am | Danica Marinac-Dabic, MD, PhD, Director, CDRH/OSB/DEPI, Post-Approval Studies: Current Practices and Vision for the Future |
| 9:40 am | Thomas Gross, MD, MPH, Deputy Director, CDRH/OSB, Sentinel Initiative |
| 10:00 am | Coffee Break |
Opportunities for Innovative Study: Critical role of registries
Moderator: Hesha Duggirala, PhD, MPH, CDRH/OSB/DEPI/EERB1
(20 min each and one 45-min Panel)
Critical role of registries:
| 10:15 am | Priscilla Velentgas, PhD, Outcome Sciences, Novel Uses and Designs of Registries |
| 10:35 am | Richard E. Kuntz, MD, MSc, Medtronic Neuromodulation, Methods and Product Performance Estimation Capability of Postmarket Registries |
| 10:55 am | Kristi Mitchell, MPH, American College of Cardiology, Professional Society Efforts |
| 11:15 am | Panel Discussion and Audience Participation: Speakers plus Paul Voorhorst, MS, MBA, DePuy Orthopaedics and Laura McKain, MD, Kendle International |
| 12:00 pm | Lunch |
Opportunities for Innovative Study: Claims/Coding Data Sources and Active Surveillance Data Sources
Moderator: Michelle Tarver-Carr, MD, PhD, CDRH/OSB/DEPI/EERB1
(20 min each and one 45 min Panel)
Claims/coding data sources:
| 12:50 pm | Suzanne L. West, MPH, PhD, RTI International, Uses, Challenges, Limitations |
| 1:10 pm | Suzanne L. West, MPH, PhD, RTI International, Electronic Medical Records |
Active surveillance:
| 1:30 pm | Frederic Resnic, MD, MSc, Brigham and Women's Hospital, DELTA |
| 1:50 pm | Robert L. Davis, MD, MPH, Center for Health Research, Southeast, Vaccine Safety Data Link |
| 2:10 pm | Panel Discussion and Audience Participation: Speakers plus Marcel Salive, MD, MPH, CMS |
| 2:55 pm | Break |
Opportunities for Innovative Study: Design
Nesting of Post-Approval Studies in Randomized Controlled Trials and Registries
Moderator: Ellen Pinnow, MS, Branch Chief, CDRH/OSB/DEPI/EERB1
(20 min each and one 45 min Panel)
Nesting of Post-Approval Studies in Randomized Controlled Trials and Registries
| 3:10 pm | Mingdong Zhang, MD, MPH, PhD, Biosense Webster, CABANA |
| 3:30 pm | David C. Naftel, PhD, University of Alabama at Birmingham, INTERMACS |
| 3:50 pm | Penny Mohr, MA, Center for Medical Technology Policy, Large Simple Trials |
| 4:10 pm | Susan D. Horn, PhD, International Severity Information Systems, Practice-Based Evidence Study Design |
| 4:30 pm | Panel Discussion and Audience Participation: Speakers plus Elise Berliner, PhD, AHRQ; David Rutledge, PharmD, Abbott Vascular; Tom Armitage, MD Medtronic CardioVascular |
| 5:15 pm | End of Day 1 |
Day 2 (September 10)
| 8:00 am | Breakfast |
Advanced Epidemiologic/Statistical Methods
Moderator: Art Sedrakyan, MD, PhD, CDRH/OSB/DEPI (20 min each and one 45 min Panel)
| 9:00 am | Ciprian M. Crainiceanu, PhD, Johns Hopkins University, Bayes/Semi-Bayes |
| 9:20 am | Daniel O. Koralek, MA, MS, PhD, Pfizer, Meta-analysis/Systematic Literature Review |
| 9:40 am | Sharon Lise Normand, PhD, Harvard Medical School, Research Synthesis |
| 10:00 am | Stephen J. Gange, PhD, Johns Hopkins University, Misclassification |
| 10:20 am | Coffee Break |
| 10:35 am | David C. Naftel, PhD, University of Alabama at Birmingham, Sub-group Analysis |
| 10:55 am | Til Stürmer, MD, MPH, University of North Carolina at Chapel Hill, Selection Bias and Dealing with Confounding |
| 11:15 am | Panel Discussion and Audience Participation: Speakers plus Pablo Bonangelino PhD, FDA/CDRH/OSB/DBS/GSDB; Xuefeng Li, PhD, FDA/CDRH/OSB/DBS/GSDB; Marianthi Markatou, PhD, Columbia University, CBER/OBE |
| 12:00 pm | Lunch |
Measurement Considerations
Moderator: Daniel Caños, MPH, CDRH/OSB/DEPI/EERB1
(20 min each and one 45 min Panel)
| 1:00 pm | Madhu Mazumdar, PhD, MS, MA, Weill Medical College of Cornell University, Multi-level Data: Important Considerations When Attempting to Fully Understand Device/Operator Performance |
| 1:20 pm | Mary Beth Ritchey, RN, MSPH, PhD, CDRH/OSB/DEPI/EERB1, The Missing Data Problem: Baseline Demographics, Procedural Variables, and Loss to Follow-Up |
| 1:40 pm | Kristen Van Dole PhD, MSPH, CDRH/OSB/DEPI/EERB2, Quality of Life/Patient Reported Outcomes |
| 2:00 pm | Panel Discussion and Audience Participation: Laurie B. Burke, RPh, MPH, CDER/OND |
| 2:45 pm | End of Workshop |
Registration
To register for the conference please visit the following Website:
https://medsun2.S-3.net/FDAPASWkshpSep09
There is no fee to attend the workshop, but attendees must register in advance.
Contacts
The workshop organizer may be contacted at:
Daniel Caños
Epidemiologist
Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health,
Food and Drug Administration
10903 New Hampshire Ave
WO-66-4120
Silver Spring, MD 20993
Phone: (301) 796–6057
e-mail: daniel.canos@fda.hhs.gov