Rochester, Minnesota




The primary research interests of Qian Shi, Ph.D., are in the area of the conduct and methodology of clinical trials in cancer. Dr. Shi works to develop innovative statistical study design to run more efficient clinical trials that deliver effective, novel treatments to patients with cancer. Additional areas of active research include evaluation and methodology of surrogate endpoints, meta-analyses of individual patient data from a large collection of clinical trials, survival analysis, and prognostic and predictive biomarker analysis.

Focus areas

  • Dr. Shi leads statistical aspects of multiple ongoing large randomized clinical trials of both therapeutic and surgical cancer treatment. She provides statistical design and supervises study monitoring, including patient safety, data collection, statistical analyses, regulatory reporting and publications.
  • Dr. Shi leads the Sargent's Hypothesis Analysis in the Research of Endpoint (SHARE) team. This independent statistics and data center team supports meta-database integration and analysis projects for the following large international collaborations, including Adjuvant Colon Cancer End Points (ACCENT), Analysis and Research in Cancers of the Digestive System (ARCAD), International Duration Evaluation of Adjuvant Chemotherapy (IDEA), Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) group, Surrogate Endpoints for Aggressive Lymphoma (SEAL) group, and International Independent Team for Endpoint Approval of Myeloma Minimal Residual Disease (iiTEAMM).
  • Dr. Shi leads projects evaluating and validating surrogate endpoints for oncology clinical trials through collaborations between academic and industry institutions, and supporting Food and Drug Administration and European Medicines Agency qualification applications.

Significance to patient care

The research conducted by Dr. Shi contributes to an increased understanding of tumor genetics and patient factors that make disease more or less aggressive, and provides innovations in conducting oncology clinical trials. When successful, the clinical trials that Dr. Shi participates in directly contribute to new treatment options for patients with cancer.

Professional highlights

  • Director for statistics, Statistics and Data Management Program, Alliance for Clinical Trials in Oncology, 2019-present
  • Lead consulting statistician, Gastrointestinal Cancer Program, Mayo Clinic Comprehensive Cancer Center, 2016-present
  • Lead statistician, Gastrointestinal Committee, Statistics and Data Center, Alliance for Clinical Trials in Oncology, 2016-present
  • Editorial board member, Journal of Clinical Oncology, 2015-present
  • Lead voting statistician, Data Safety and Monitoring Board, Mayo Clinic Comprehensive Cancer Center, 2014-present


Primary Appointment

  1. Consultant, Division of Clinical Trials and Biostatistics, Department of Quantitative Health Sciences

Academic Rank

  1. Professor of Oncology
  2. Professor of Biostatistics


  1. PhD - Biostatistics Thesis title: Bayesian Methods of Evaluation and Use of Surrogate Endpoints in Single-Trial Settings. Thesis Advisors: Mary Kathryn Cowles and Kathryn Chaloner. University of Iowa
  2. MS - Biostatistics University of Iowa
  3. BS - Pharmaceutics China Pharmaceutical University

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