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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.


Events

ASA Biopharmaceutical Section FDA-Industry Statistics Workshop - September 22 - 24, 2014.


Washington Marriott Wardman Park, Washington, DC.

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