Researchers Improving Clinical Trials to Get Cancer Therapies to Patients Sooner

Researchers from North Carolina State University, the University of North Carolina at Chapel Hill and Duke University have teamed up to find ways to design more powerful clinical trials for cancer treatments, effectively getting better and more personalized new therapies to cancer patients sooner.

The researchers have been awarded a $12.5 million, 5-year grant from the National Cancer Institute to develop new methods for the design and analysis of cancer clinical trials.

“Statistical Methods for Cancer Clinical Trials,” is one of the largest grants of its kind to be awarded by the National Cancer Institute. The project is led by three principal investigators: Dr. Michael R. Kosorok, professor and chair of the biostatistics department of the UNC Gillings School of Global Public Health; Dr. Marie Davidian, William Neal Reynolds Professor of Statistics and director of the Center for Quantitative Sciences in Biomedicine at NC State; and Dr. Stephen L. George, professor of biostatistics at Duke. The project will support a major collaborative, multidisciplinary effort that takes advantage of the unrivaled concentration of leading statistical and clinical experts across the three institutions and the two highly-rated cancer centers at UNC and Duke. The leadership team also includes three co-principal investigators: Dr. Joseph G. Ibrahim, Alumni Distinguished Professor of Biostatistics and director of the Center for Innovative Clinical Trials at UNC; Dr. Sin-Ho Jung, professor of biostatistics at Duke; and Dr. Anastios A. Tsiatis, Drexel Professor of Statistics at NC State.

In addition to Davidian and Tsiatis, five NC State faculty from the Department of Statistics, Drs. Howard Bondell, Dennis Boos, Leonard Stefanski, Jung-Ying Tzeng, and Hao Helen Zhang, will serve as investigators on the project. These faculty will contribute expertise in areas including clinical trial design and analysis, development of predictive models from high dimensional data, and statistical methods for uncovering disease genes.

Clinical trials are controlled studies in humans that evaluate the value of prevention, diagnosis, or treatment methods, such as chemotherapy, radiotherapy, or surgery. The effectiveness of almost all advances in cancer treatment must be evaluated in clinical trials before being adopted in clinical practice.

Statisticians play an integral role in designing trials, analyzing and interpreting the results to determine if they are meaningful, and developing new methods for design and analysis in settings where traditional methods are inappropriate. The project’s statistical researchers will work with its clinical investigators to apply state-of-the-art statistical techniques to address the challenges for trial design and analysis posed by complex clinical endpoints, diagnostic markers, personalized medicine, and sequential courses of treatment in melanoma, breast, colorectal, lung, and prostate cancer settings. The goal is to dramatically improve the efficiency of the cancer clinical trial process and ultimately to improve the health and longevity of cancer patients.

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