Past Events


For events yet to occur, see the current listing.

JSM 2014

August 2 – 7, 2014 | Boston, Massachusetts

The 2014 Joint Statistical Meetings took place in Boston,Massachusetts.

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.

JSM 2013

August 3 – 8, 2013 | Montréal, Québec

The 2013 Joint Statistical Meetings took place in Montreal, Quebec, Canada.

Topic Contributed Sessions at JSM 2013 Organized by SIGMEDD

SIGMEDD members presented 24 papers on statistical issues related to therapeutic and diagnostic medical device study in 5 topic contributed sessions at JSM this year.

25 - Statistical Issues in Assessing Performance of Diagnostic Devices
Sponsored by Section on Statistics in Epidemiology, Biopharmaceutical Section, ASA Special Interest Group for Medical Devices and Diagnostics (SIGMEDD)

473 - Practice of Quantitative Decision Analysis in Regulatory Science for Medical Devices
Sponsored by Section on Bayesian Statistical Science, International Society for Bayesian Analysis (ISBA)

518 - Blinding and Placebo Effects in Randomized Clinical Trials
Sponsored by Biopharmaceutical Section, ASA Special Interest Group for Medical Devices and Diagnostics (SIGMEDD), Mental Health Statistics Section, Biometrics Section, Section for Statistical Programmers and Analysts

634 - Challenges and advances in evaluation of clinical trials
Sponsored by Biopharmaceutical Section, ASA Special Interest Group for Medical Devices and Diagnostics (SIGMEDD), Mental Health Statistics Section, Biometrics Section

673 - Challenging Statistical Issues in Medical Device Trials
Sponsored by Biopharmaceutical Section, ASA Special Interest Group for Medical Devices and Diagnostics (SIGMEDD)

2013 Annual Meeting

5 – 6 PM, Monday, August 5, 2013 | Room CC-516d

SIGMEDD's 2013 Annual Meeting, the last of the interest group that preceded the MDD Section, took place at JSM 2013.

JSM 2012

July 28 – August 2, 2012 | San Diego, California

The flagship conference and gathering for the American Statistical Association and its international allies, Joint Statistical Meetings lets statisticians from around the globe share presentations, attend workshops, network and meet, and of course experience a new locale. The conference also hosts each year's SIGMEDD General Meeting. JSM 2012 took place in San Diego, California, from July 28 to August 2.

Topic Contributed Sessions

SIGMEDD members presented 39 papers on statistical issues related to theraputic and diagnostic medical device study in 9 topic contributed sessions.

Annual Meeting 2012

SIGMEDD held its 2012 annual business meeting on July 30 at JSM in San Diego, California. The meeting, chaired by SIGMEDD chair Greg Campbell, was attended by approximately 50 members. The membership voted overwhelmingly to take steps to move from an Interest Group to an ASA Section - Section on Medical Devices and Diagnostics (MDD) of the American Statistical Association.

Other issues:

  • ASA requires a minimum of 100 signatures from its members to form a new section. More than 60 signatures have been collected at the JSM (during SIGMEDD's annual business meeting). We ask for your support in signing the petition.
    Click here to download a petition form. Any ASA members are eligible and welcome to sign.
  • The current SIGMEDD charter will need to be amended to meet the requirements of a section charter. Greg will form a committee to make the necessary revisions, with the goal of finishing by the end of the year.
  • Members voted to approve the dues for the Section of Medical Devices and Diagnostics (MDD) to be $10, same as the Biopharmaceutical Section.
  • Nominations are needed for next year's SIGMEDD officers. The offices that would need to be filled this year are Chair-Elect (Chair in 2014), Program Chair-Elect (Program Chair in 2014), and Correspondence Secretary. The slate of officers for the new Section of Medical Devices and Diagnostics (SMDD) would be SIGMEDD officers holding office in 2013-2014. For this purpose, two additional officers, a treasurer and an elected representative to the Council of Sections will be elected in this election.
  • A four-member nomination committee, Peter Lam (Chair), Aaron Lobbestael, Greg Maislin, and Shanti Gomatam, has been formed to handle the officer election. Please consider nominating a person (including yourself) for each post. Please e-mail your nominations to Peter Lam and copy the other members of the committee.

JSM 2011

July 30 – August 4, 2011 | Miami Beach, Florida

JSM 2011 took place in Miami Beach, FL, from July 31 to August 5. SIGMEDD presented 7 topic contributed sessions at the annual Joint Statistical Meetings at Miami Beach, Florida, between July 30 and August 4, 2011.

>> ASA: JSM 2011

JSM 2010

July 31 – August 5, 2010 | Vancouver, BC, Canada

JSM 2010 took place in Vancouver, BC, from July 31 - August 5. SIGMEDD presented 9 medical devices and diagnostics related sessions at JSM 2010.

>> ASA: JSM 2010

Topic Contributed Sessions

sponsored by the Biopharmaceutical Section; ENAR

Invited Sessions

sponsored by the Statistics in Epidemiology, Biometrics, Bayesian Statistical Science, Health Policy Statistics, Statistical Programmers and Analysts Sections; Committee on Career Development; WNAR and International Chinese Statistical Association

SIGMEDD Annual Meeting

As traditional, SIGMEDD's 2010 Annual Meeting took place at the Joint Statistical Meetings.

JSM 2009

August 1-6, 2009 | Washington D.C.

The 2009 Joint Statistical Meetings conference was held from August 1-6, 2009, in Washington D.C. SIGMEDD organized 8 topic contributed sessions on statistical issues of medical devices and diagnostics at JSM 2009. All sessions were well attended.

>> ASA: JSM 2009

Sponsored by the Biopharmaceutical Section

Sponsored by the Statistics in Epidemiology Section

SIGMEDD Annual Meeting 2009

A business meeting of the Special Interest Group for Medical Devices and Diagnostics was held on Monday, August 3, 2009 at JSM. A draft charter of the special interest group was presented to 70 attendees by Greg Campbell; it is viewable on the Charter page.

AdvaMed/FDA-CDRH Statistical Workshop 2009

April 29 – 30, 2009 | Gaithersburg, MD

The second annual AdvaMed/FDA-CDRH Statistical Workshop took place in Gaithersburg, MD from April 29 - 30, 2009. The agenda can be viewed here.

Content from the first annual AdvaMed/FDA-CDRH Statistical Workshop (April 16-17, 2008) is also available: Agenda and presentations