SUMMARY
Sumithra J. Mandrekar, Ph.D., is the lead faculty statistician for lung cancer research at Mayo Clinic. She is also the program director, group statistician and Mayo Clinic principal investigator for the Alliance for Clinical Trials in Oncology — also called Alliance — and the Alliance Foundation Trials. As such, she has the overall scientific, administrative and fiscal responsibility for all statistics and data management for Alliance's trials and research. Dr. Mandrekar also is the lead faculty statistician for Alliance's experimental and rare tumors committee.
Dr. Mandrekar's research interests are in the areas of design, conduct and analysis of cancer clinical trials with a focus on trial implementation and methodology. She has designed and coordinated phase 1, 2 and 3 clinical trials for over 20 years, including trials that have led to regulatory approval of agents, and several research grants in the field of oncology.
Focus areas
- Clinical trial conduct and methodology.
- Dose-finding trial designs.
- Designs for biomarker validation.
- Tumor measurement-based clinical trial end points.
Significance to patient care
Issues relating to clinical trial conduct and design include patient selection, choice of end points, choice of design, control arm and biomarkers. These play an important role in the understanding and translation of clinical research to practice.
Precision medicine seeks to develop specialized therapies for treating individuals or groups based on their unique characteristics. An optimal clinical trial design can help with precision medicine by improving the success rate of clinical drug development. Other benefits of an effective trial design include reducing trial costs related to patients and resources, as well as preventing patient exposure to toxic treatments that may not benefit them.
Professional highlights
- National Cancer Institute:
- Co-chair, Streamlining Clinical Trials Implementation Committee, 2023-present.
- Co-chair, Clinical and Translational Research Advisory Committee, Streamlining Clinical Trials Working Group, 2022-present.
- Member, Clinical and Translational Research Advisory Committee, 2020-present.
- Program director and group statistician, Alliance for Clinical Trials in Oncology, 2016-present.
- Biostatistics editor, Journal of Thoracic Oncology, 2011-present.
- Adjunct professor of biostatistics, School of Public Health, University of Minnesota, 2008-present.
- Member, Thoracic Malignancy Steering Committee, National Cancer Institute, 2008-present.
- President, Society for Clinical Trials, 2019.