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 session proposals due 1/16/2016

For JSM 2016, Chicago, topic contributed session proposals are due January 16 (tomorrow!). Submit your proposal here. For the sponsoring section, select Section on Medical Devices and Diagnostics.

ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

The 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop will be held September 28-30 at the Washington Marriott Wardman Park in Washington, DC. The program committee is currently accepting abstracts for the following: Roundtable Luncheons Deadline: March 15, 2016 Poster Sessions NEW for 2016! Deadline: April 1, 2016 For the first time, the workshop will feature poster sessions. The program committee is seeking abstracts highlighting current, relevent research in the areas of regulatory and industry statistics. Please click here on how to submit your abstract.

Statistical Methods in Economic Evaluations Workshop May 2, 2016

Statistical Methods in Economic Evaluations Workshop May 2, 2016 Renaissance Arlington Capital View Hotel, Arlington, VA 2800 South Potomac Ave, Arlington, VA, 22202, (703) 413-1300 Economic evaluations play an integral role in informing health care policy decisions. These studies often rely on data from clinical trials, prospective registries, and secondary data. The availability of patient-level data allows analysts to apply conventional and innovative statistical methods to patient-level data. Using examples, the faculty will examine statistical approaches that address common features of resource use and cost data, including distributional characteristics, censoring, hierarchical data structures, and potential confounding. Additional statistical issues that arise when combining patient-level estimates of costs and effectiveness will also be discussed.

This workshop is considered "Day 0" to the 9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference. Professionals often attend both the workshop and the conference. The conference will be held the day after the workshop. To register, go to here.

9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference May 3-4, 2016

9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference May 3-4, 2016 Renaissance Arlington Capital View Hotel, Arlington VA 2800 South Potomac Ave, Arlington, VA, 22202, (703) 413-1300 This annual conference brings together leading authorities from FDA, industry and academia to address statistical topics through two tracks- therapeutic device and diagnostics. Keynote Speaker: Robert M. Califf, Deputy Commissioner for Medical Products and Tobacco for the U.S. Food and Drug Administration. To register, go to here.

New FDA National Medical Device Evaluation Plan

On behalf of the American Statistical Association (ASA) Section on Medical Devices and Diagnostics (MDD), Greg Pappas wrote an article on the new FDA National Medical Device Evaluation Plan (attached). It was published in the December 2015 issue of the Amstat News (2nd attachment), a monthly publication that every member of the ASA receives. The article is great visibility for the FDA National Medical Device Plan and the MDD ASA Section. The article is available here.

A 15-Year History of Bayesian Device Trials: A Consultant's Perspective

Scott Berry, PhD and former SIGMEDD Chair, presented the first MDD Webinar on April 9, 2015. Missed it live? The slides are still available here.

Invited Sessions sponsored by Section on Medical Devices and Diagnostics at JSM 2015

13 - Recent Developments in Bayesian Medical Device and Drug Trials.

  • Detecting and Accounting for Violations of the Constancy Assumption in Non-Inferiority Clinical Trials.
    Joe Koopmeiners, University of Minnesota; Brian Hobbs, M.D. Anderson Cancer Center.
  • Bayesian Nonparametric Models for Comparative Effectiveness.
    Gary L. Rosner, Johns Hopkins Medicine; Chenguang Wang, Johns Hopkins Medical.
  • Bayesian Analysis of Heterogeneous Treatment Effect in Patient-Centered Outcomes Research.
    Ravi Varadhan, Johns Hopkins University; Thomas A. Louis, Johns Hopkins SPH & U. S. Census Bureau; Chenguang Wang, Johns Hopkins Medical.
  • Discussant: David Draper, University of California, Santa Cruz, and eBay Research Labs.

334 - Recent Developments in Biomarker Evaluation.

  • Some statistical method in bridging efficacy studies for companion diagnostic tests.
    Xiao-Hua Zhou, University of Washington.
  • Evaluation of the programmatic performance (repeated application) of a screening test.
    Gene Anthony Pennello, Food and Drug Administration.
  • Measures to evaluate biomarkers as predictors of incident cases and connection to information theory.
    Patrick Heagerty, University of Washington; Jason Liang, University of Washington.
  • Discussant: Li Meijuan, FDA.

Topic Contributed Papers sponsored by Section on Medical Devices and Diagnostics at JSM 2015

121 - Minimizing bias in medical device trials through study design and data analysis.

  • Study Design Using Bayesian Conditional Borrowing of the Prior with Multiple Cutoffs.
    Peter Lam, Boston Scientific; Songtao Jiang, Boston Scientific; Ming-Hui Chen, University of Connecticut.
  • Sensitivity Analysis for Clinical Trials with Missing Outcome Data Using Repeated Measures - A Simulation Study Design.
    Terry Liao, Boston Scientific Corporation; Ying Yang, FDA.
  • Minimizing Bias in Observational Comparative Clinical Studies.
    Lilly Yue, FDA/CDRH.
  • Practical considerations for establishing monitoring committees in device trials for ensuring trial validity.
    Rajesh Nair, CDRH/FDA.
  • Discussant: Greg Campbell, FDA/CDRH.

405 - Moving Beyond Fixed Biomarker Trial Designs.

  • Adaptive Enrichment Designs with Population Selection Based on a Continuous Biomarker.
    Michael Rosenblum, Johns Hopkins Bloomberg School of Public Health.
  • Auto-adaptive Alpha Allocation: a strategy to mitigate risk on study assumptions.
    Yue Shentu, Merck and Co., Inc.; Cong Chen, Merck Research Labs, Merck & Co., Inc.; Lei Pang, Merck & Co.
  • The application of group sequential stopping boundaries to evaluate the effect of an experimental agent across a range of marker expression.
    Eric Holmgren, Oncomed.
  • Designing a confirmatory trial with a continuous biomarker endpoint and an undetermined threshold tested at both the interim and final.
    Adarsh Joshi, Gilead Sciences ; Jenny Zhang, Gilead Sciences; Nusrat Rabbee, Gilead Sciences; Liang Fang, Gilead Sciences.
  • The statistical issues and challenges for follow-on companion diagnostic devices.
    Meijuan Li, US Food and Drug Administration.

594 - Statistical Challenges and Novel Methodologies for Evaluating The Clinical Performance of Diagnostic Devices.

  • Study design and analysis issues for diagnostic monitoring devices.
    Bipasa Biswas, CDRH, FDA.
  • Measuring agreement in method comparison studies with repeated measurements.
    Zhiheng Xu, FDA; Meijuan Li, US Food and Drug Administration.
  • A statistical method for method comparison studies when outcomes can only assume monotone.
    Yuqing Tang, US Food and Drug Administration; Meijuan Li, US Food and Drug Administration; Jincao Wu, FDA.
  • Dynamic Placement Values: A Basis for Evaluating Prognostic Potential.
    Aasthaa Bansal, University of Washington; Patrick Heagerty, University of Washington; Paramita Saha-Chaudhuri, McGill University; Jason Liang, University of Washington.
  • Reference Interval - of the posterior distribution.
    Jeng Mah, Beckman Coulter; Mark Holland Beckman Coulter.

Regular Contributed Papers sponsored by Section on Medical Devices and Diagnostics at JSM 2015

189 - Design and analysis of pivotal studies for medical devices.

  • Considerations in using registry data to support pre-market applications of medical devices.
    Nelson Lu, FDA/CDRH; Lilly Yue, FDA/CDRH; Yunling Xu, FDA/CDRH.
  • Adaptive Sample Size Re-estimation with Fisher's Exact Test and a Promising Zone.
    Tyson Rogers, NAMSA; Scott McKane, Respicardia, Inc.
  • Considerations in Sample Size, Type I Error, and Power for 2-group Non-inferiority Study Using Farrington-Manning Method.
    Son