Statistical Methods for Cancer Clinical Trials (P01 CA142538) Renewed
Michael Kosorok, Marie Davidian, and Kouros Owzar
Michael
Kosorok
Marie
Davidian
Kouros
Owzar

We are excited to report that our Program Project grant from the National Cancer Institute, “Statistical Methods for Cancer Clinical Trials” (P01 CA142538), which provides the primary support for IMPACT investigators, students, and research staff, has been renewed for another five years!

Originally awarded in 2010, the grant has supported our work on five previous, interrelated research projects, all addressing various aspects in cancer clinical trial design and analysis. In the renewal period, which runs until March 2020, we’ll build on our progress on these projects and on other advances in the statistical, biologic, genomic, and computational sciences to develop and disseminate new statistical methods that will accelerate progress toward the goal of personalized cancer medicine. Our work will speak directly to the considerable interest in personalized treatment in the research community and among the public, as emphasized by the White House Precision Medicine Initiative and the National Institutes of Health.

Personalized Medicine
© PersonalizedMedicine.com

Our original five research projects traversed a broad range of issues in clinical trials: the needs for methods for design of studies involving complex endpoints (previous Project 1); for handling the inevitable missing data that arise and for incorporating patient information to improve precision of analyses (previous Project 2); for combining the results of previous trials to gain new insights and inform design of future trial (previous Project 3); for pharmacogenomics, identifying genetic/genomic determinants of differences in how patients respond to and experience adverse reactions to cancer therapies (previous Project 4); and for developing “treatment algorithms,” or treatment regimes, that use evolving individual patient characteristics to guide the sequential decisions involved in ongoing cancer treatment (previous Project 5).

In the new five-year grant period, we’ll continue the themes of previous Projects 1, 3, 4, and 5, refining the focus of each toward cutting edge challenges posed by personalized medicine discovery. Project 1 is developing innovative trial designs and accompanying analytic methods that integrate biomarkers, biological measures that may reflect disease status, predict outcomes, or be associated with response to treatment, for efficient discovery and validation of personalized treatments. Project 2 is creating new methods for analysis of retrospective data collected from clinical trials, and epidemiological and medical registries, to identify potential candidate biomarker components, including patient reported outcomes such as quality of life, to improve design of clinical trials for personalized medicine. Project 3 is continuing the efforts of previous Project 4 to maximize the power of cancer pharmacogenomics for identifying biomarkers and candidate personalized therapies. Finally, Project 4 is extending our work on analytic methods and novel clinical trial designs for developing personalized treatment regimes for sequential decision-making, with specific focus on addressing issues such as the trade-off between maximizing efficacy and minimizing toxicity that arise in cancer treatment.

We’ll continue creating software implementing almost all of our methods and make it available here on our website, and we’ll also be developing online tutorials that will allow the researcher community to “test drive” our software. And IMPACT will again host symposia, as we did in 2011, 2012, and 2014, bringing together our personnel and top researchers from across the world to present state-of-the-art work related to the theme of personalized/precision medicine.

Please contact us if you are interested in learning more about IMPACT and our research!

Submit a question or comment.
Welcome to the IMPACT Blog!

Each month, one of our program investigators will introduce him/herself and will discuss their research, new research directions, or advancements made toward our goal of improving the clinical trial process. Readers are encouraged to send questions or comments. In addition, we will announce new software releases, publications, and upcoming events.

Subscribe

Archive
blog icon
By: Xiaofei Wang and Jianwen Cai
Date: February 15, 2016
blog icon
By: Michael Kosorok
Date: December 16, 2015
blog icon
By: Shannon Holloway
Date: November 24, 2015
blog icon
By: Donglin Zeng
Date: October 15, 2015
blog icon
By: Alison Motsinger-Reif
Date: September 17, 2015
blog icon
By: Shannon Holloway
Date: August 24, 2015
blog icon
By: Michael R. Kosorok, Marie Davidian, and Kouros Owzar
Date: June 4, 2015