Rochester, Minnesota




Sumithra J. Mandrekar, Ph.D., is the lead faculty statistician for lung cancer research at Mayo Clinic and for the Alliance for Clinical Trials in Oncology and the Alliance Foundation Trials. She is the group statistician for the Alliance for Clinical Trials in Oncology and statistical director for the Alliance Foundation Trials, with overall scientific, administrative and fiscal responsibility for all statistics and data management activities for trials and research the organizations coordinate. She is also the lead faculty statistician for the experimental and rare tumors committee of these two organizations.

Dr. Mandrekar has been involved in multiple phase 1, 2 and 3 clinical trials, including trials that led to regulatory approval of agents, and several research grants in oncology over the last 18 years. Dr. Mandrekar's research interests are in the areas of design and analysis of clinical trials in cancer and in clinical trial conduct and methodology.

Focus areas

  • Clinical trial conduct and methodology
  • Dose-finding trial designs
  • Designs for initial and definitive biomarker validation
  • Tumor measurement-based clinical trial endpoints

Significance to patient care

The translation of clinical research to practice in the field of oncology has been slow, despite a growing understanding of the genetic and molecular basis of this disease. While myriad factors impact this slow pace of progress, issues relating to clinical trial conduct and design play a significant role, including patient selection, choice of endpoints, choice of design, control arm, along with issues related to biomarkers and precision medicine.

An optimal clinical trial design can help with precision medicine by improving the success rate of clinical drug development, reducing trial costs related to patients and resources, and preventing patients from being exposed to toxic treatments that may not benefit them.

Professional highlights

  • Member, National Cancer Institute Clinical and Translational Research Advisory Committee, 2020-present
  • Group statistician, Alliance for Clinical Trials in Oncology, 2016-present
  • Statistical director, Alliance Foundation Trials, 2016-present
  • Biostatistics editor, Journal of Thoracic Oncology, 2011-present
  • Adjunct professor of biostatistics, School of Public Health, University of Minnesota, 2008-present
  • Member, National Cancer Institute Thoracic Malignancy Steering Committee, 2008-present


Primary Appointment

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

Academic Rank

  1. Professor of Biostatistics
  2. Professor of Oncology


  1. PhD - Interdisciplinary - Statistics, Psychology, Internal Medicine and Biomedical Engineering Ohio State University
  2. MS - Statistics Ohio State University
  3. MSc - Mathematics Indian Institute of Technology
  4. BSc - Mathematics University of Madras

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