Research

My primary research interests are clinical trial designs for biomarker validation and alternative endpoints for Phase II clinical trials, and study designs to address missing data using a principal stratification and potential outcomes framework.

Publications (select publications; see PubMed for more complete listing)

  • Alternative Endpoints
    • An MW, Han Y, Meyers J, Bogaerts J, Sargent DJ, Mandrekar SJ.  Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.  Journal of Clinical Oncology.  2015.
    • An MW, Dong X, Meyers J, Han Y, Grothey A, Bogaerts J, Sargent DJ, Mandrekar SJ. Evaluating Continuous Tumor Measurement-Based Metrics as Phase II Endpoints for Predicting Overall Survival. Journal of the National Cancer Institute. 2015.
    • Mandrekar SJ, An MW, Meyers J, Grothey A, Bogaerts J, Sargent DJ. Evaluation of Alternate Categorical Tumor Metrics and Cut Points for Response Categorization Using the RECIST 1.1 Data Warehouse. Journal of Clinical Oncology. 2014.
    • An MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ.  Comparison of Continuous versus Categorical Tumor Measurements-Based Metrics to Predict Overall Survival in Cancer Treatment Trials.  Clinical Cancer Research. 2011.
  • Designs
    • An MW, Lu X, Sargent DJ, Mandrekar SJ. The direct assignment option as a modular design component: an example for the setting of two predefined subgroups. Computational and Mathematical Methods in Medicine. 2015.
    • An MW, Mandrekar SJ, Edelman MJ, Sargent DJ. Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment. Contemporary Clinical Trials. 2014.
    • Mandrekar SJ, An MW, Sargent DJ A review of phase II trial designs for initial marker validation. Contemporary Clinical Trials. 2013.
    • An MW, Mandrekar SJ, Sargent DJ.  A two-stage phase II design with direct assignment option in stage II for initial marker validation.  Clinical Cancer Research.  2012.
  • Designs to address missing data
    • An MW, Frangakis CE, Yiannoutsos CT. Choosing profile double-sampling designs for survival estimation with application to President’s Emergency Plan for AIDS Relief evaluation. Statistics in Medicine. 2014.
    • Yiannoutsos CT, An MW, Frangakis CE, Musick BS, Braitstein P, et al. Sampling-Based Approaches to Improve Estimation of Mortality among Patient Dropouts: Experience from a Large PEPFAR-Funded Program in Western Kenya. PLoS ONE. 2008.
    • An MW, Frangakis CE, Musick BS, Yiannoutsos CT. The need for double-sampling designs in survival studies: An application to monitor PEPFAR. Biometrics. 2008.
    • Frangakis CF, Rubin DB, An MW, MacKenzie EJ. Principal Stratification Designs to Estimate Input Data Missing due to Death (with discussion). Biometrics. 2007.