Medical Devices and Diagnostics Newest ASA Section

摘要

One of the ASA's special interest groups became a section at the beginning of this year. SIGMEDD, the Statistical Interest Group for Medical Devices and Diagnostics, has officially become the Medical Devices and Diagnostics Section (MDD) of the American Statistical Association. The common term "medical devices" incorporates many categorically different products: heart valves, pacemakers, artificial joints, maggots, laboratory tests for diagnostic medicine, and software for medical deci-sionmaking, to name just a few. Assessment of performance for such a heterogeneous group requires a wide spectrum of trial designs, such as Bayesian and adaptive methodologies. Many trials differ from the classical drug trial setting (e.g., randomization and masking often are not feasible). In addition, diagnostic tests have a unique set of challenges, and they have gained increased prominence due to the burgeoning interest in personalized medicine.