Special Interest Group
Medical Devices and Diagnostics: JSM
2009 and Beyond
Arkendra De, Jeng Mah, and Estelle Russek-Cohen
M
edical devices include all kinds of gad-
gets, including heart valves, artificial
joints, in vitro diagnostics, and software
that drive medical decisionmaking. Many study
design issues are different from classic drug trials,
and one finds greater use of Bayesian and adaptive
The many “under construction” sections present-
designs and studies where randomization is not fea-
ly on the web site clearly reflect the fledgling look of
sible. Personalized medicine poses new statistical
the group, itself. As SIGMEDD develops, the web
challenges, including the assessment of a drug that
site will improve. Upcoming modifications include
comes with a companion diagnostic. Attendees at
housing papers and presentations related to our spe-
JSM this year can learn more about the statistical
cial interest and increasing the web page’s visibility
issues of medical devices and diagnostics at eight
by connecting to and from other web sites. ■
topic-contributed sessions and the annual Special
Interest Group in Medical Devices and Diagnostics
(SIGMEDD) meeting.
Medical device sessions sponsored by the
Biopharmaceutical Section include “Statistical
Analysis of Medical Device Data,” “Statistical Topics Rao Prize Conference Set
in the Study of Medical Devices,” “Propensity Scores
and Bayesian Methods for Historical Controls and
Observational Studies,” “Missing Data Handling in
for Penn State
Medical Device Clinical Trials,” and “Postmarket
Issues in Medical Devices.” The Section on Statistics
in Epidemiology is sponsoring three diagnostic
device sessions: “Study Design Issues for Diagnostic
Devices,” “Machine Learning and Computational
T
he Department of Statistics at
Penn State University will
hold a one-day conference on
Inference for Diagnostic Devices,” and “Statistical
May 22, 2009. The highlight of the
Analysis Issues for Diagnostic Devices.” For more
conference will be the award of the
information about these sessions and the annual
2009 Rao Prize to Peter J. Bickel of
SIGMEDD meeting, visit
www.amstat.org/sections/
the University of California, Berkeley.
sigmedd. Everyone interested in medical devices is
The prize was established by C. R. and
welcome to attend.
Bhargavi Rao to honor outstanding and
influential innovations in the theory and practice
Rao
SIGMEDD is more than a JSM activity. It pro-
vides an opportunity for FDA statisticians, aca-
of mathematica l statistics, international leadership
demics, and company statisticians to interact on
in directing statistics research, and pioneering contributions
common statistical issues. The main conduit for
by a recognized leader in the field of statistics.
communicating SIGMEDD’s activities—its web
The conference program consists of four invited speakers and a gradu-
page—has existed since December 2007 and can
ate student poster presentation. The invited speakers are C. F. Jeff Wu of
now be found through Google. Like www.amstat.
the Georgia Institute of Technology, Willem van Zwet of the University
org, the SIGMEDD web page is intended to be a
of Leiden, Jianqing Fan of Princeton University, and Bickel.
virtual home base—a public face—for the special
For more information about the conference, visit www.stat.psu.
interest group. Statisticians interested in medical
edu/~richards/raoprize/2009.html. ■
device and diagnostics can use it to track activities
and communicate with others interested in medical
device statistical issues.
MAY 2009 AMSTAT NEWS 17
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