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.




The American Statistical Association's Newest Section

The Special Interest Group in Medical Devices and Diagnostics (SIGMEDD) has become the ASA's Medical Devices and Diagnostics Section.

As a section, we are entitled to participate in all ASA activities. MDD has organized and sponsored multiple topic contributed sessions at JSM 2014. Please plan to attend these sessions in Boston, MA. Stay Tuned for more information.

Thank you everyone for your support during the petition process. You can join the MDD section now. Especially please don’t forget to join the Medical Devices and Diagnostics Section when you renew your ASA membership (students can join for $1).

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

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.

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.

Method comparison and benefit risk evaluation for diagnostic devices

  • Assessing the benefit risk tradeoff in diagnostic devices.
    Norberto Pantoja-Galicia, FDA/CDRH.
  • 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.
    Shanti Gomatam, FDA/CDRH.
  • Bias reduction in the design and analysis of imaging studies.
    Phil Lavin, Lavin Consulting.
  • Discussion.
    Tom Gwise, FDA.


SIGMEDD Annual Meeting 2013

SIGMEDD's annual meeting at JSM was held at 6 PM on Monday, August 5, 2013.

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)

SIGMEDD Sessions at past JSM

SIGMEDD presented 39 papers in 9 well-attended topic contributed sessions at JSM 2012.

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


Events

7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop - April 29 - 30, 2014.

Marriott at Metro Center, Washington, DC
Get more information about this workshop
Registration now open.

JSM 2014 - August 2 - 7, 2014, Boston, MA


More information

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

Washington Marriott Wardman Park, Washington, DC.
Get more information about this workshop


Founding

Meet the current officers of MDD.

MDD Charter

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


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