Cooperative Agreement U01FD007206

The National Science Foundation (NSF) awarded a $131,858 Project Grant to The Trustees of Columbia University in the City of New York, Sponsored Projects Administration Division (Columbia University), under the Social, Behavioral, and Economic Sciences program (CFDA 47.075). The grant funds research to develop statistical approaches that improve the external validity of randomized controlled trials (RCTs) in the social sciences. Specifically, the research will make two key methodological...

This Project Grant from the National Science Foundation's Division of Mathematical Sciences, under the Mathematical and Physical Sciences program (CFDA 47.049), provides $186,606 to Duke University to support research developing new algorithms and modeling techniques for optimal adaptive enrichment design in randomized clinical trials. The goal is to address increasing costs that negatively impact public health by reducing willingness to undertake clinical trials and delaying new drug...

This Project Grant award from the National Science Foundation (NSF) under the Mathematical and Physical Sciences program (CFDA 47.049) provides $180,000 to the University of North Carolina at Chapel Hill to develop an efficient statistical framework for improving individualized treatment decisions in personalized medicine. The key products and services to be delivered include: 1) Advancing methods for estimating optimal individualized treatment rules that can handle complex relationships among...

This federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $1,549,414 to Harvard Pilgrim Health Care Inc. to study the validity of linked real-world data (RWD) for diabetes mellitus research. The key objectives of the 4-year project, titled "Improving the Validity of Linked Real-World Data Studies for Diabetes Mellitus Research...

This Project Grant award from the National Heart Lung and Blood Institute (CFDA 93.837 - Cardiovascular Diseases Research) provides $706,573.00 to Yale University to develop novel statistical methods for analyzing multiple and composite outcomes in cluster-randomized trials (CRTs) focused on improving patient care for heart failure. The project aims to: 1) create efficient covariate-adjusted estimators for "win" statistics (net benefit, win ratio, win odds) in CRTs with multivariate...

The U.S. Food and Drug Administration (FDA) awarded a $1.45M Cooperative Agreement under the FDA Research program (CFDA 93.103) to the Academy of Managed Care Pharmacy to conduct a study titled "Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals." The project aims to evaluate the feasibility and validity of using real-world data from the U.S., Italy, and Denmark to emulate a biosimilar interchangeability (switching) study. The results will be...

This Project Grant award of $367,876 from the National Institute of Environmental Health Sciences (NIEHS) under the Medical Library Assistance (CFDA 93.879) program supports research to develop robust Bayesian adaptive designs and methods for multi-arm, multi-dose, multi-stage platform clinical trials. The research aims to address practical challenges in real-world platform trials, such as optimizing sequential monitoring, establishing proof-of-concept and dose selection, managing...

This Project Grant from the National Science Foundation Division of Information and Intelligent Systems provides $625,000 to Duke University to develop an interpretable artificial intelligence framework for improving care of critically ill patients. The framework incorporates novel matching techniques known as Almost-Matching-Exactly to analyze observational data from patient treatment and emulate a randomized controlled trial. By matching each treated patient to similar untreated patients,...

This Project Grant award from the Agency for Healthcare Research and Quality (AHRQ) under the Research on Healthcare Costs, Quality and Outcomes program (CFDA 93.226) supports a $400,000 randomized trial to evaluate the impact of a "whole person navigation" intervention for adults with multiple chronic conditions. The intervention combines predictive modeling to identify high-risk patients with a navigation strategy to help guide them in accessing social services and overcoming...

This Project Grant award from the National Institute on Aging (CFDA 93.866 - Aging Research) provides $778,499 to the University of Texas Health Science Center at Houston to develop novel machine learning models to reveal and stratify heterogeneous subpopulations of Alzheimer's disease (AD) patients based on risk and progression patterns. The goal is to transform these subpopulations into potentially targetable groups to enable focused clinical trials, support future therapeutic development, and...