Sumithra J. Mandrekar, Ph.D.

Sumithra J. Mandrekar, Ph.D., is the primary statistician for the lung cancer clinical trials research program both at Mayo Clinic and in the Alliance for Clinical Trials in Oncology, as well as for the Mayo Clinic Cancer Prevention Network. She is involved in multiple clinical trials and research grants in these areas.

Dr. Mandrekar's research interests are in the areas of design and analysis of clinical trials in cancer.

Focus areas

• Dose-finding trial designs
• Designs for initial and definitive biomarker validation
• Tumor measurement-based clinical trial endpoints
• Pooled analyses

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 a myriad of factors impact this slow pace of progress, issues relating to clinical trial design play a significant role, including patient selection, choice of endpoints, choice of control arm and assay-related issues.

An optimal design can help improve the success rate of clinical drug development, bring down trial costs in terms of patients and resources, and prevent patients from being exposed to toxic treatments that may not benefit them.

Professional highlights

• Adjunct Associate Professor of Biostatistics, School of Public Health, University of Minnesota, 2008-present
• Member, Thoracic Malignancy Steering Committee, National Cancer Institute, 2008-present
• Biostatistics Editor, Journal of Thoracic Oncology, 2011-present
• Director of Biostatistics, Alliance for Clinical Trials in Oncology, 2011-present
• Member, Clinical Imaging Steering Committee, National Cancer Institute, 2011-present
• Associate Director, Biostatistics Shared Resource, Mayo Clinic Cancer Center, 2012-present