Innovative Methods Program for Advancing Clinical Trials (IMPACT) 

A joint venture of the University of North Carolina at Chapel Hill, Duke University and North Carolina State University. 

IMPACT is a comprehensive program that aims to improve dramatically the health and longevity of people by improving the clinical trial process. 

The primary source of funding for this project is the National Cancer Institute through a program project (P01 CA142538) grant entitled "Statistical Methods for Cancer Clinical Trials." 

Our approach is to leverage recent advances in biologic, genomic, statistical, and computational sciences to create new clinical trial designs and data analysis tools that resolve many of the key scientific limitations of current statistical methods and that maximize the effectiveness of clinical trials for personalized cancer medicine. 

Our research focuses on four topics:

  1. new trial designs and analysis methods that integrate biomarkers,
  2. analysis methods of existing data on biomarkers and outcomes to improve the design of future studies,
  3. pharmacogenomics for identifying biomarkers and candidate individualized therapies, and
  4. discovering and validating sequential, personalized decision-making strategies for cancer treatment.

Previous research areas addressed by the program include practical design and analysis problems in Phase II and Phase III clinical trials, the problem of missing data and efficient use of prognostic information, post-marketing surveillance and comparative effectiveness research using clinical trial data, and pharamcogenetics and individualized therapies.