Karla V. Ballman, Ph.D., is actively engaged in the development, implementation, conduct, and reporting of national, multicenter clinical trials in cancer.
At the present time, she is focusing on trials for women with breast cancer and trials for elderly patients, but she has also been involved in trials for patients with brain cancer, lung cancer, gastrointestinal stromal tumors and prostate cancer.
Her work in cancer also involves the development and testing of tools that use genomic information to help guide patient treatment. Dr. Ballman also provides statistical leadership in clinical research focused on surgical questions.
- Lead statistician for the Alliance for Clinical Trials in Oncology (Alliance) Breast Cancer Committee. In this role, Dr. Ballman collaborates with the Alliance Breast Cancer Committee chairs in moving the scientific agenda of the group forward, which includes providing statistical leadership in the support of the group's studies. In addition, she is the study statistician for several phase III trials for women with breast cancer.
- Lead statistician for the Alliance Cancer in the Elderly Committee. In this role, Dr. Ballman collaborates with the Alliance Cancer in the Elderly Committee chairs in setting the scientific agenda of the group and providing statistical leadership for the studies conducted by the group.
- Co-lead statistician for the Mayo Clinic Department of Surgery. As a member of the Department of Surgery Research Executive Committee, Dr. Ballman provides statistical leadership to ensure high-quality clinical research study design and analyses. She also collaborates on the design of clinical trials conducted by investigators within the Department of Surgery.
- Validation of squamous cell carcinoma genomic signatures. Dr. Ballman is the director of the Biostatistical Center for a consortium of six institutions that are validating several different genomic signatures to identify squamous cell carcinoma patients who are at higher risk of disease recurrence within three years of their curative-intent surgery. Her work in this area is to develop the necessary methodology for validating existing signatures based on genomic data and develop new signatures for predicting patient outcome.
- Clinical trial and statistical methodology. Dr. Ballman is interested in developing clinical trial methodology that is applicable to establishing efficacy of an intervention with a relatively small sample size. She is also involved in developing statistical methodology for creating robust signatures of high-dimensional data for purposes of disease diagnosis, prediction of clinical outcome, and prediction of response to therapy.
Significance to patient care
Dr. Ballman's work in clinical trials has resulted in practice changes for the treatment of cancer. Two specific examples are:
- The demonstration that eliminating axillary lymph node dissection in women who have 1-2 positive sentinel lymph nodes does not result in poorer survival
- The use of adjuvant imatinib (Gleevec) in patients with newly resected gastrointestinal stromal tumors significantly increases recurrence-free survival in these patients
Her work in the area of developing robust molecular signatures that can predict response to therapy will help realize the goal of providing therapy that is tailored to the specifics of a patient's disease.