Statistical Issues in Medical Devices and Diagnostics

Marriott Gaithersburg Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD
April 29 - 30, 2009

Wednesday, April 29

Statistics in Medical Devices & Diagnostics – an Overview
Speaker: Gregory Campbell (FDA)

The Use of Adaptive Design
In this session, several device clinical studies with adaptive design will be presented, some utilizing frequentist adaptive approach and some Bayesian approach.
Speakers: Roseann White (Abbott Vascular), David Snead (J&J), Scott Berry (Berry Consultants), Yonghong Gao (FDA)

The Application of Bayesian Statistics
This session is intended to supplement the FDA guidance by providing more detailed guidance as to when to use Bayesian methodology and to present several examples where it has been applied to diagnostic and device trials.
Speakers: Andrew Mugglin (Paradigm Biostatistics/University of Minnesota), Norman Preston (Abbott Diagnostics), A. James O’Malley (Harvard), Telba Irony (FDA)

Multiplicity
This session is intended to discuss adjusting for multiple endpoints. The speakers will address the appropriate adjustments in design and analysis when analyzing primary and secondary endpoints and multiple endpoints, from Bayesian as well as frequentist perspectives.
Speakers: Gene Pennello (FDA), Kevin Najarian (Boston Scientific), Shiowjen Lee (FDA), Zengri Wang (Medtronic), Andrew Mugglin (Paradigm Biostatistics/University of Minnesota)

Issues with Missing Data
This session will consider why data are missing, statistical assumptions for the missingness -- MCAR, MAR, MNAR -- and how to handle missing data -- LOCF, BOCF, multiple imputation, and sensitivity analyses.
Speakers: Sherry Yan (FDA), Geert Molenberghs (Hasselt University, Belgium), Jason Roy (Geisinger Health System), Recai Yucel (SUNY-Albany)

Thursday, April 17

Trial Design – No Controls Available or Imperfect Controls
This session provides a brief overview of non-randomized or trials with imperfect controls in medical device clinical studies in terms of design and statistical analysis from industry and regulatory perspectives, and discusses challenges through case studies.
Speakers: Steve Broste (Medtronic), Lilly Yue (FDA), Bryan Randall (Boston Scientific), Lei Peng (Abbott Vascular), Brandon Sparks (Medtronic)

Data Poolability
Poolability comprises a heterogeneous set of problems that need to be addressed on a case by case basis. This session will consist of presentations by both FDA and the industry regarding their perspectives on this issue followed by the panel discussion.
Speakers: Chul Ahn (FDA), John Evans (Boston Scientific), Jeng Mah (American Medical Systems)

Statistical Issues in Diagnostics and Imaging
There are two parts to this all-afternoon session. Part A will explore some of these concerns, including co-development of biomarkers and assays, special problems encountered in diagnostic imaging studies, and quality control issues. Part B will discuss the multiple aspects of diagnostic products that need to be evaluated. To assist in evaluating some of these characteristics, guidance documents have been published through the joint efforts of interested parties.
Speakers: Marina Kondratovich (FDA), Angel DeGuzman (Abbott Diagnostics), Jan Krouwer (Krouwer Consulting), Lakshmi Vishnuvajjala (FDA), Dan Sargent (Mayo Clinic), Tom Gwise (FDA), Kyungsook Kim (FDA), Estelle Russek-Cohen (FDA)

Postmarket Statistical Issues
With the increasing complexity of medical devices and diagnostics, including drug/device combination products, the need for well designed post marketing studies that will adequate demonstrate safety in a “real world” setting is critical. This session will discuss the challenges in designing and analyzing these studies through examples and case studies. Speakers: Chang S. Lao (FDA), Wenji Pu (Medtronic), Peter Lam (Boston Scientific), Yuqing Dai (Medtronic)