An Integrated Clinical Risk Assessment System for Chemotherapy and Myelotoxicity

DESCRIPTION (provided by applicant): Proventys, Inc. has developed predictive modeling and decision support software that assists oncologists in making evidence-based decisions, to maximize benefit and minimize risks associated with chemotherapy. This SBIR application focuses on predictive modeling of febrile and severe neutropenia and anemia in patients receiving chemotherapy for early stage breast cancer (ESBC). Oncologists routinely make chemotherapy decisions without access to risk-related evidence or t o modeling tools that can qualify risk for the individual patient. In this SBIR, Proventys will implement: (1) a risk modeling system that flexibly incorporates new models and that can be used to locally validate data and biomarkers, and (2) Chemotherapy Solutions, a physician-targeted software interface providing evidence-based decision support that is convenient, has robust predictive power, and is both flexible and cost-effective for institutions ranging from large HMOs and medical centers to small onc ology practices. The novel modeling technology will generalize to prediction of risk associated with numerous cancer therapeutics, and will readily integrate with existing electronic medical records (EMRs). Phase I specific aims are: (1) To incorporate pre dictive models for ESBC/chemotherapy risk and outcomes into Proventys' Model Library. (2) To validate the system's accuracy in predicting adverse chemotherapy outcomes in ESBC patients; we will conduct this test in an out-of-sample dataset of Duke cancer p atients. (3) To create a clinical analysis framework for recommend-ing optimal therapeutic choices, based on five-year survival probability and risks of febrile/severe neutropenia and anemia. (4) To build Chemotherapy Solutions upon this framework. (5) To assess (a) providers' satisfaction with Chemotherapy Solutions, via physician focus groups, and (b) the effect of this tool on prescribing choices, using a simulated trial with mock patient data and an expert clinical panel. At the end of Phase I, Proventy s will have: enhanced its Predictive Modeler and Model Library with additional well-studied, validated, predictive models; created a clinical analysis framework that predicts specific risks associated with chemotherapy for the targeted diseases; and built and assessed a physician-targeted decision support software tool. In Phase II, focused on cultivating commercial potential of Chemotherapy Solutions, we will: further develop predictive models, conduct a larger prospective trial, integrate the tool with st andard EMRs, build user-friendly data input modules, and incorporate a cost-effectiveness selection feature, among other enhancements. We will continue to cultivate relationships (already initiated) with major HMOs, insurance corporations, and medical cent ers during Phase II, in preparation for full commercialization of Chemotherapy Solutions and the broader Proventys family of Clinical Solutions in Phase III.This Phase I SBIR project, proposed by Proventys, Inc., will lead to the implementation of a clinic al decision support tool that assist oncologists in improving health outcomes for cancer patients preparing to undergo chemotherapy. This cost-effective, web-based tool will be suitable for broad utilization in oncology provider organizations ranging from small group practices to large academic medical centers and HMOs. The SBIR effort will also result in powerful enhancement of the Proventys Model Library and Risk Assessment System, which will open new avenues of medical research to further improve care of cancer patients.