UG1CA287013

Statistics and Data Management Center (SDMC) for the NCI Cancer Screening Research Network (CSRN) - multi-cancer detection assays offer new opportunities to screen for many different cancers that currently have limited options for early detection. The Cancer Screening Research Network (CSRN) will conduct definitive clinical trials and studies to evaluate these assays.

Design and implementation of screening trials involve many challenges. Cancer incidence and death are rare events in an average risk population. Trial designs must balance screening frequency, trial duration, and sample size to achieve trial objectives in a cost-efficient manner.

Implementation must anticipate issues such as non-adherence, non-compliance, and contamination. Analysis must accommodate the design while adapting to the circumstances of implementation. The Statistics and Data Management Center (SDMC) of the CSRN will offer a rigorous system for CSRN trial design, management and analysis so that the information generated by CSRN trials forms a sound basis for national cancer screening policy.

Our team brings together statistical leaders and clinical trial management experts with experience in major clinical trials networks, including the Women’s Health Initiative Clinical Coordinating Center, the SWOG Statistics and Data Management Center and the Early Detection Research Network Data Management and Coordinating Center. We have expertly designed, implemented, analyzed and reported cancer screening, prevention, and treatment trials.

This work has required developing procedures and processes for expert execution of trials and production of reliable results. It has necessitated creating close collaborations with clinicians, scientists, patient advocates, and subject matter experts. And, particularly in the case of screening trials, it has inspired development of novel statistical methods that have become established in the field.

Our goal is to promote excellence in all aspects of statistical and data management for the CSRN. To address the critical questions regarding potential benefits and risks of new cancer screening methodologies, the CSRN clinical trials must be designed and implemented with great integrity and efficiency to produce the most knowledge possible within realistic constraints of time and resources.

To attain these goals, the SDMC for the CSRN has four specific aims: (1) integrate the SDMC with the other CSRN components. (2) provide rigorous and high-quality designs and analysis for CSRN studies. (3) build a state-of-the-art data system to ensure data quality and integrity for CSRN trials. (4) develop statistical and data management approaches to a large CSRN screening clinical trial that would build upon the Vanguard Study.

MCD testing represents a potential paradigm shift for cancer early detection. Successful execution of these aims will ensure that the CSRN produces valid and reliable quantitative results concerning the efficacy and benefit-harm tradeoffs of candidate products to support evidence-based policies concerning their use.

Fred Hutchinson Cancer Center

TO REDUCE CANCER RISK, INCIDENCE, MORBIDITY, AND MORTALITY AND ENHANCE QUALITY OF LIFE IN CANCER SURVIVORS THROUGH AN ORDERLY SEQUENCE FROM RESEARCH ON INTERVENTIONS AND THEIR IMPACT IN DEFINED POPULATIONS TO THE BROAD, SYSTEMATIC APPLICATION OF THE RESEARCH RESULTS THROUGH DISSEMINATION AND DIFFUSION STRATEGIES. PRIMARY EMPHASIS IS ON THE INCLUSION OF CANCER PREVENTION AND CONTROL INTERVENTION(S) IN ANY PROPOSED STUDY. CANCER PREVENTION AND CANCER CONTROL RESEARCH STUDIES ARE CLASSIFIED INTO ONE OF FIVE PHASES: (1) HYPOTHESIS DEVELOPMENT, (2) METHODS DEVELOPMENT AND TESTING, (3) CONTROLLED INTERVENTION TRIALS TO ESTABLISH CAUSE-AND-EFFECT RELATIONSHIPS, (4) RESEARCH IN DEFINED POPULATIONS, AND (5) DEMONSTRATION AND IMPLEMENTATION STUDIES. PRIMARY INTERESTS ARE IN RESEARCH ON CANCER CONTROL INTERVENTIONS IN PHASES 2 THROUGH 5, AND ON CANCER PREVENTION RESEARCH IN ALL PHASES. CANCER PREVENTION AND CONTROL PROGRAMS INCLUDE THOSE IN THE FOLLOWING AREAS: (1) CANCER EPIDEMIOLOGY, (2) CANCER COMMUNICATIONS, (3) NUTRITION, DIET, AND PHYSICAL ACTIVITY, (4) SCREENING AND EARLY DETECTION IN HEALTH CARE DELIVERY, (5) BIOBEHAVIORAL MECHANISMS, (6) TOBACCO CONTROL, (7) HEALTH DISPARITIES RESEARCH, (8) SUPPORTIVE CARE AND SURVIVORSHIP, (9) HEALTH SERVICES AND OUTCOMES RESEARCH, AND (10) SURVEILLANCE RESEARCH. CANCER CONTROL USES SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS TO ENGAGE DOMESTIC SMALL BUSINESS CONCERNS IN FEDERAL RESEARCH AND DEVELOPMENT THAT HAS POTENTIAL FOR COMMERCIALIZATION. THE GOALS OF THE SBIR & STTR PROGRAMS ARE TO STIMULATE TECHNOLOGICAL INNOVATION, INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF FEDERAL RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERALLY FUNDED RESEARCH AND DEVELOPMENT, AND FOSTER PARTICIPATION BY SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE STTR PROGRAM REQUIRES THE SMALL BUSINESS CONCERN TO FORMALLY COLLABORATE WITH A RESEARCH INSTITUTION IN PHASE I AND PHASE II OF THE PROGRAM.

93.399 - Cancer Control

National Cancer Institute (NCI) [HHS - NIH]

Washington United States

State-Wide

NCI Cancer Screening Research Network: Statistics and Data Management Center (UG1 Clinical Trial Required) (RFA-CA-23-021)

Amendment Since initial award the total obligations have increased 330% from $808,823 to $3,477,537.