Researchers from the University of North Carolina at Chapel Hill, Duke University and N.C. State University have been awarded a five-year, $10.4 million grant by the National Cancer Institute to continue determining ways to design more powerful clinical trials for cancer patients, effectively delivering better and more personalized new therapies to cancer patients sooner.
The award, “Statistical Methods for Cancer Clinical Trials,” was funded originally for $12.5 million in 2010 and is one of NCI’s largest grants of this type.
Michael R. Kosorok, PhD, W.R. Kenan Jr. Distinguished Professor and chair of biostatistics at UNC’s Gillings School of Global Public Health and a member of the UNC Lineberger Comprehensive Cancer Center, is the contact principal investigator for the project. Marie Davidian, PhD, William Neal Reynolds Professor of Statistics and director of the Center for Quantitative Sciences in Biomedicine at N.C. State, and Kouros Owzar, PhD, professor of biostatistics and bioinformatics at Duke, are also principal investigators.
The project supports 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.
Other Gillings School biostatistics faculty members in leadership roles on the grant are Joseph G. Ibrahim, PhD, Alumni Distinguished Professor and director of the Center for Innovative Clinical Trials at UNC; Jianwen Cai, PhD, professor and associate chair; and Danyu Lin, PhD, Dennis Gillings Distinguished Professor.
Other schools, departments and centers across the UNC campus are involved on the project, including the UNC Eshelman School of Pharmacy, UNC Lineberger, the Gillings School’s health policy and management department and others. Leaders also include Xiaofei Wang, PhD, associate professor of biostatistics and bioinformatics at Duke; Anastasios A. Tsiatis, PhD, Drexel Professor of Statistics at N.C. State; and Shannon Holloway, PhD, 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 into clinical practice.
Statisticians play an integral role in designing trials, analyzing and interpreting the results to determine whether they are meaningful, and developing new methods for design and analysis in settings where traditional methods are inappropriate. The project’s statistical researchers work with 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 improve dramatically the efficiency of the cancer clinical trial process and ultimately to improve the health and longevity of cancer patients.
“We are thrilled that to have the privilege to continue working on this project to advance cancer clinical trials, especially in the area of personalized medicine,” Kosorok said. “We look forward to working together with our many collaborators at UNC, N.C. State and Duke.”