Projects
Statistical Methods for Prospective Evaluation of Biomarkers
Role: PI
This long-standing NIH-funded research program is dedicated to developing innovative statistical methodologies for the design and analysis of biomarker discovery and validation studies. Our primary focus is on prospective clinical studies, particularly in the context of early cancer detection, screening, surveillance, and prognosis. We address key challenges in outcome ascertainment within prospective cohort designs and develop robust methods for evaluating biomarker performance in real-world clinical settings. A central component of our work involves creating and validating dynamic, adaptive surveillance strategies that integrate multiple biomarkers and testing modalities to enhance disease monitoring.
Improve the Design and Analysis of Randomized Screening Trial in a New Era of Cancer Early Detection
Role: MPI
Novel blood tests offer a noninvasive way to detect cancer early. However, despite the simplicity of these tests, follow-up actions from the test results may be costly or harmful. The quick introduction of these tests requires reevaluating how novel early-detection biomarkers are assessed.
Large screening trials are often needed when evaluating new cancer screening tests, where participants randomly receive new screening tests or usual care. These trials take a long time to assess if the new test lowers the chances of dying from cancer. Researchers have proposed to look at short-term results, but sometimes, big drops in these results may not mean significant reductions in cancer deaths. Better approaches to studying these tests, considering the benefits and potential harms they might cause, are urgently needed.
This study aims to improve the design and analysis of randomized screening trials so that researchers can more quickly learn if the new tests can reduce the probability of cancer deaths and if they are harmful. Improving how the randomized screening trials are designed and analyzing the study results can speed up the evaluation process of new screening tests. This could lead to faster sharing of effective screening methods to the public and provide balanced information about their benefits and harms for shared and informed decision making. It will ultimately help reduce the disease burden and improve patients' outcomes.
Early Detection Research Network Data Management and Coordinating Center
Role: Contact PI
The mission of the Early Detection Research Network (EDRN) is to discover, develop and validate biomarkers and imaging methods to detect early stage cancers and to assess risk for developing cancer, and to translate these biomarkers and imaging methods into clinical tests. A consortium of more than 300 investigators at academic institutions and in the private sector are working collaboratively to bring biomarkers and imaging methods to clinical use.
The EDRN DMCC, funded in 2000, provides logistical support and coordination for 59 institutions in EDRN; coordinates meetings, conference calls, and workshops; develops and manages the EDRN secure website; collaborates with the Jet Propulsion Laboratories to maintain the EDRN public portal; participates in the review of validation studies and associate member applications; manages and coordinates EDRN validation studies; develops and maintains the Validation Study Information Management System (VSIMS) for data collection and management; specimen tracking and study monitoring; and conducts statistical methodology research for EDRN.
Liquid Biopsy Consortium
Role: Contact PI
In the era of personalized medicine, it is desirable to have noninvasive or minimally invasive methods to determine and follow longitudinally the molecular composition and characterization of a patient’s tumor, which will help gain a broader understanding of the disease. One such approach is through liquid biopsy that can be used to molecularly characterize the tumor and monitor genetic changes over time using repeat sampling of biofluids. Liquid biopsy generally refers to detecting circulating tumor cells (CTC), circulating tumor DNA (ctDNA), circulating exosomes and other analytes in body fluids, such as serum, plasma, urine, etc. The NCI’s Division of Cancer Prevention has developed and sponsored an Academic/Industrial Partnership program designed to advance and validate Liquid Biopsy technologies specifically targeted for early stage cancer detection. Liquid biopsy uses body fluids such as blood, urine, saliva, stool, and sputum from patients suspected to have early stage cancer as well as those at high risk of developing cancer. The Liquid Biopsy Consortium is also working on methods to distinguish cancer from benign disease; or aggressive from indolent cancers. Projects focus on the development of new tools/methods/assays and/or validations of existing technologies/methods involving the capture of DNA, RNA, or exosomes in circulating body fluids.
Coordinating Center for Population-based Research to Optimize Cancer Screening (PROSPR)
Role: MPI
Cancer screening is a complex, multi-step process where benefits are maximized when each step is completed successfully, but where sub-optimal outcomes are frequent as a result of breakdowns that can happen at any point in this process. Screening is also impacted by factors beyond simply individual patients including factors at the provider-, practice-, and health plan/institution-level and these so-called system-level factors can impact the appropriate delivery of high quality cancer screening services. PROSPR was established to address a number of critical questions related to the delivery of cancer screening in the United States, and our PROSPR I Statistical Coordinating Center (SCC) was central to many of the successes of this initiative including: 1) Developing a trans-organ conceptual model of cancer screening processes, 2) Creating common data elements and screening performance metrics, 3) Evaluating individual and systems-level factors impacting screening performance, 4) Establishing PROSPR data repositories and creating an infrastructure for publicly sharing PROSPR data. The Specific aims for PROSPR II PCC are: 1) Provide administrative coordination for the PROSPR network and guidance in the development of PROSPR governance, organization, and policies/procedures; 2) Lead the development of common conceptualization and measures for: A. Assessing the role of systems-level factors that impact the screening process. B. Assessing screening quality; 3) Facilitate trans-PROSPR research comparing the screening process across at least 2 organ sites; and 4) Develop and implement processes and procedures to share PROSPR data with qualified investigators outside of the PROSPR network.
Canary PASS
Role: Lead Statistician
The Canary Prostate Active Surveillance Study (PASS) is a multi-center research study for people who have chosen active surveillance to manage their prostate cancer. Active surveillance in PASS means closely monitoring men with prostate cancer and offering treatment if test results show the cancer is getting worse.
Prostate cancer is the most common cancer among men. In the U.S. in 2017, there will be approximately 160,000 men diagnosed with prostate cancer, and about 26,500 deaths from prostate cancer. Prostate cancer treatment choices are complicated because the majority of prostate cancers will not be lethal, even if left untreated. Doctors cannot always tell which cancers can remain untreated and which will become more aggressive. As a result, some men may receive treatment unnecessarily and some men may not receive sufficient treatment. This study seeks to discover markers to distinguish aggressive cancers from less aggressive cancers. We aim to develop new tests and better strategies to help men decide if and when their cancers need treatment. Information from PASS may help develop better tests to predict prostate cancer outcomes.
There are 11 clinical sites enrolling patients across the U.S. and Canada in addition to the coordinating center based at the Fred Hutchinson Cancer Research Center, in Seattle.
COMPASS
Role: Director
As a program within the Biostatistics Program in the Public Health Sciences Division of Fred Hutch Cancer Center, COMPASS has been directing multi-center studies in public health research for over 30 years.
COMPASS provides study project management and coordination; logistical support; data management and statistical support; Institutional Review Board (IRB) monitoring and compliance; quality control/quality assurance through data review and site visits; web-based data collection and management systems and specimen tracking systems.
The COMPASS organization was formed in 1983 when we established and began coordinating the Carotene and Retinol Efficacy Trial (CARET), a multi-center lung cancer prevention trial. In early 2024, CARET moved to the Cancer Prevention Program under Dr. Marian Neuhouser.
In 2000, we began to expand and now manage several large-scale research networks and studies, including the Early Detection Research Network (EDRN), Early Detection Initiative (EDI), Liquid Biopsy Consortium (LBC), New-Onset Diabetes (NOD) cohort, Prostate Active Surveillance Study (PASS) and the Translational Liver Cancer (TLC) Consortium, and have been involved in numerous smaller collaborations.