Qian Shi, Ph.D.

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SUMMARY

The research interests of Qian Shi, Ph.D., focus on the methodology of clinical trials for cancer. Dr. Shi works to develop innovative statistical study designs 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, and prognostic and predictive biomarker analysis.

Focus areas

• Statistical aspects of multiple large randomized clinical trials of both therapeutic and surgical cancer treatments. Dr. Shi leads the statistical team supporting these trials. She also provides statistical design and supervises study monitoring. This includes patient safety, data collection, statistical analyses, regulatory reporting and publications.
• Sargent's Hypothesis Analysis in the Research of Endpoints (SHARE) team. Dr. Shi leads this team, which has been the independent statistics and data center for multiple international large database collaborations. This team supports meta-database integration and analysis projects for these large international collaborations:
  • Adjuvant Colon Cancer End Points (ACCENT).
  • Analysis and Research in Cancers of the Digestive System (ARCAD).
  • Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) group.
  • International Duration Evaluation of Adjuvant Chemotherapy (IDEA).
  • International Independent Team for Endpoint Approval of Myeloma Minimal Residual Disease (i2TEAMM).
  • Measurable Residual Disease Partnership and Alliance in Acute Myeloid Leukemia Clinical Treatments (MPAACT).
  • Surrogate Endpoints for Aggressive Lymphoma (SEAL) group.
• Surrogate endpoints for oncology clinical trials. Dr. Shi leads multiple research efforts to evaluate and validate surrogate endpoints for oncology clinical trials through collaborations between academia and industry. With her team, Dr. Shi also supports qualification applications to regulatory agencies, including:
  • U.S. Food and Drug Administration.
  • European Medicines Agency.
  • National Institute for Health and Care Excellence.

Significance to patient care

Dr. Shi's research plays a part in learning more about tumor genetics and patient factors that make disease more or less aggressive. Her research also provides innovations to conduct faster and more efficient oncology clinical trials. When successful, the clinical trials that Dr. Shi participates in directly add to new treatment options for patients with cancer.

Professional highlights

• Associate editor, Cancer Research Communications, American Association for Cancer Research, 2021-present.
• Member, lower gastrointestinal tract expert panel, American Joint Committee on Cancer, 2020-present.
• Voting member, Gastrointestinal Steering Committee, National Cancer Institute, 2020-present.
• Alliance for Clinical Trials in Oncology:
  • Lead statistician, gastrointestinal committee, Statistics and Data Management Center, 2016-present.
  • Director of statistics, Statistics and Data Management Program, 2019-2021.
• Mayo Clinic Comprehensive Cancer Center:
  • Lead faculty statistician, Gastrointestinal and Hepatobiliary Cancers Program, 2016-present.
  • Statistical co-chair, Data Safety and Monitoring Board, 2014-2024.
  • Director, Biostatistics Shared Research, Cancer Center Support Grant, 2021-2023.
• Grant review panel member, Cancer Prevention Study Section, National Institutes of Health, 2020-2024.