Arkendra De

There will be a SIGMEDD meeting at JSM this year on August 2. Anyone interested in medical devices and diagnostics is welcome to attend. Check the online program for the updated time and location.

The term “medical devices” incorporates many products, including heart valves, pacemakers, artificial joints, maggots, laboratory tests for diagnostic medicine, and software for medical decisionmaking. To assess performance for such a heterogeneous group requires a wide spectrum of trial designs, including Bayesian and adaptive. Many of the trial designs differ from the classical drug trial setting, since randomization is not always feasible. In addition, laboratory tests have a unique set of challenges, and they have gained increased prominence due to the burgeoning interest in personalized medicine.

JSM 2010 attendees can learn about the statistical issues of medical devices and diagnostics at any of the following nine topic-contributed and invited sessions:

• Statistical Methods in Medical Device Studies
• Statistical Considerations in the Design and Conduct of Medical Device Studies
• Challenging Statistical Issues in Medical Device Trials
• Adaptive Design for Drug/Diagnostic Combination Trials
• Challenges and Methods for Evaluating Diagnostic Devices and Medical Device Software
• Data Analysis Issues in Medical Device Studies Invited
• Statistics and Development of Personalized Medicines
• Bayesian Approach for Safety and Efficacy Analyses
• Risk Stratification Markers: Applications to Public Health and Clinical Medicine

JSM is not the only forum for statisticians interested in medical devices and diagnostics. The Statistical Interest Group for Medical Devices and Diagnostics (SIGMEDD), has been functioning as an ASA special interest group for three years. SIGMEDD brings together statisticians who share an interest in statistical challenges in medical devices and diagnostics.

The main conduit for communicating SIGMEDD’s activities is its website. Statisticians interested in medical devices and diagnostics can use it to track activities and communicate with others interested in statistical issues for medical devices.