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Improving Clinical Trials, Speeding New Cancer Therapies Focus of New NIH Grant to Area Researchers

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Duke Health News 919-660-1306

Researchers from Duke University Medical Center, the University of North Carolina at Chapel Hill, and North Carolina State 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, five-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, which is part of the National Institutes of Health.

The project is led by three principal investigators: Stephen L. George, PhD, professor of biostatistics at Duke; Michael R. Kosorok, PhD, professor and chair of the biostatistics department of the UNC Gillings School of Global Public Health; and Marie Davidian, PhD, William Neal Reynolds Professor of Statistics and director of the Center for Quantitative Sciences in Biomedicine at N.C. State.

The project will support a major collaborative, multidisciplinary effort that takes advantage of the unrivaled concentration of leading statistical and clinical experts at the three campuses, as well as the two highly-rated cancer centers at Duke and UNC.

The leadership team also includes three co-principal investigators: Joseph G. Ibrahim, PhD, Alumni Distinguished Professor of Biostatistics and director of the Center for Innovative Clinical Trials at UNC; Sin-Ho Jung, PhD, professor of biostatistics at Duke; and Anastasios A. Tsiatis, PhD, Drexel Professor of Statistics at N.C. State.

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 of 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.

More than $2.5 million from the National Cancer Institute will fund the first year of the project.

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