Welcome to MDD

The American Statistical Association Section on Medical Devices and Diagnostics (MDD) is composed of statisticians who are interested in applying and developing statistical methods for evaluating medical and diagnostic devices. More about MDD.

Topic Contributed Papers sponsored by Section on Medical Devices and Diagnostics at JSM 2014

225 - Strategies to mitigate against operational bias in adaptive designs for medical device trials.

  • The use of ‘fuzzy promising zones’ to mitigate against operational bias in adaptive sample-size re-estimation designs.
    Brendan Keenan, Biomedical Statistical Consulting.
  • Mitigating operational bias in adaptive design: a regulatory perspective.
    Martin Ho, FDA/CDRH.
  • Operational bias in adaptive Designs: potential sources and mitigation strategies.
    Michelle Detry, Berry Consultants.
  • Strategies to Mitigate Against Operational Bias in Adaptive Designs for Medical Device Trials.
    Caroline Morgan, Cytel.
  • Discussion.
    Charity Morgan, University of Alabama at Birmingham.

405 - Method Comparison and Benefit Risk Evaluation for Diagnostic Devices.

  • Assessing the Benefit Risk Tradeoff in Diagnostic Devices.
    Norberto Pantoja-Galicia, FDA.
  • Is There a Universe Beyond Sensitivity and Specificity in Evaluation of Diagnostic and Prognostic Performance?
    Michael Pencina, Duke University.
  • Challenges in Method Comparison for Diagnostic Devices.
    Bo Zhang, FDA.
  • Bias Reduction in the Design and Analysis of Imaging Studies.
    Philip Lavin, Lavin Consulting.
  • Discussion.
    om Gwise, FDA.

637 - Statistical issues in medical device and diagnostic trials.

  • Some notes on adaptive design in survival analysis.
    Jin Wang, Abbott Diagnostics.
  • Coefficient of Variation (CV) – What does it measure in a Quantitative Polymerase Chain Reaction (qPCR) assay?
    Jeng Mah, Beckman Coulter.
  • Receiver Operating Characteristic Curve method for evaluating surrogate endpoints in a Left Ventricular Assist Device (LVAD) trial.
    Hong Wang, HeartWare.
  • The impact of (not) stratifying the analysis by site when randomization was stratified by site.
    Brian Wiens, Alcon.
  • Statistical issues in developing pharmacogenomic biomarkers for drug and/or molecular diagnostic.
    Nusrat Rabbee.

Contributed Oral Poster Presentations: Section on Medical Devices and Diagnostics

352 - Contributed Oral Poster Presentations: Section on Medical Devices and Diagnostics

  • Metabolomics-Based Discovery of Diagnostic Biomarkers for Dengue.
    Carolyn Cotterman, Colorado State University.

Contributed Papers sponsored by Section on Medical Devices and Diagnostics at JSM 2014

297 - Design and Analysis of Therapeutic Medical Device Trials.

  • A Score Test for Detecting Heterogeneous Within-Cluster Variances in Linear Mixed Models.
    Chul Ahn, FDA/CDRH.
  • Practical Issues with Designing and Executing Bayesian Adaptive Medical Device Trials.
    Rajesh Nair, FDA/CDRH.
  • Incorporation of Prior Information in a Clinical Trial.
    Manuela Buzoianu, FDA.
  • Practical Issues on the Observational Comparative Study Design Using Propensity Score Methodology in Pre-Market Medical Device from the Regulatory Perspectives.
    Nelson Lu, FDA/CDRH.
  • Sensitivity Analysis for Clinical Trials with Missing Outcome Data: a Bayesian Tipping Point Analysis.
    Ying Yang, FDA/CDRH.
  • Simulation Exercise in Days Alive and Out of Hospital (DAOH) Endpoint.
    Peter Lam, Boston Scientific.

506 - Analysis of Diagnostic Imaging and Other Medical Data

  • Early Discussion of Breast Density and Supplemental Breast Cancer Screening: Is It Possible?
    Steven Schwager, Cornell University.
  • On the Use of MRI to Predict Individualized Treatment Strategies for Breast Cancer.
    Ying Lu, VA CSPCC/Stanford University .
  • Testing for Two Signals with Unknown Locations in a Gaussian Random Field: A Monte Carlo Simulation Study with an Application to fMRI.
    Pei-Chin Lu, University of Northern Colorado.
  • Simplified Power and Sample-Size Calculations Using Prevalence and Magnitude of Active Peaks.
    Joke Durnez, Ghent University.
  • An Analytical Variance Estimator of Partial Area Under the Empirical ROC Curve.
    Andriy Bandos, University of Pittsburgh.
  • Analytic Development of Heterogeneous Patterns.
    Hyun Kim, University of California, Los Angeles.
  • A Location-Mixture Autoregressive Model for Online Forecasting of Lung Tumor Motion.
    Daniel Cervone, Harvard University.

611 - Analysis of Diagnostic Sequencing and Related Data.

  • Statistical Issues in Cervical Screening Cytology Device Evaluation.
    Kyungsook Kim, FDA.
  • Clinical Pathoscope: Rapid Alignment and Filtration for Accurate Pathogen Identification in Clinical Samples Using Unassembled Sequencing Data.
    Joseph Perez-Rogers, Boston University.
  • Cross-Platform Gene Signature Development.
    Prasad Patil, Johns Hopkins University.
  • Statistical Scores for Rare Variant Calls in Ultra-Deep Sequencing.
    Wei-Min Liu, Roche Molecular Systems.
  • Statistical Analysis of Copy Number Variation with Sequencing Data.
    Bipasa Biswas, CDRH/FDA.
  • Modeling Receiver Operating Characteristics Curve Using Mixture of Skew-T Distriubutions.
    Amay Cheam, University of Guelph.
  • Semiparametric Covariate-Specific ROC Curve Estimation Under Test-Dependent Sampling.
    Bethany Horton, University of North Carolina at Chapel Hill.

SIGMEDD Sessions at past JSM

SIGMEDD presented 5 topic contributed sessions at JSM 2013.

For more details and other past events, see the Past Events page.


Webinar access information will be sent to the email address provided in registration before 4/9/2015. Due to space limitation, one registration per group please.

1:00 - 2:00PM EST, April 9, 2015.

Short Course

8th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop

Westin Crystal City, Arlington, VA

April 28 - 30, 2015.

Workshop Agenda

A Short Course on Adaptive Design, by Prof. Christopher Coffey

JSM 2015, August 8-13, Seattle, WA.

JSM 2015 website


Meet 2015 Officers of MDD.

MDD Charter

The MDD Charter has been approved by all members and is therefore ratified.


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