Programs

To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.

Osteoarthritis Initiative

The Osteoarthritis Initiative was a public-private collaboration to improve the efficiency of drug development and clinical trials for the treatment of osteoarthritis, which affects more than 30 million adults in the United States.

Biomarkers Consortium - Vol-PACT: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

The project seeks to analyze volumetric CT imaging trial data from completed industry phase II solid tumor trials to improve quantitative prediction of phase III results.

Biomarkers Consortium - Osteoarthritis Biomarkers Project

The Biomarkers Consortium - Osteoarthritis Biomarkers Project is a $3.4 million study aimed at determining which biomarkers have greater prognostic ability to measure early progression of structural and symptomatic changes in the joint over time and which are likely to predict treatment response better than the radiographic measurement of narrowing of joint space in knee OA patients. These new biomarkers are candidates for follow-on studies for evaluation and use in regulatory decision-making.

Biomarkers Consortium - Minimal Residual Disease (MRD) Detection in Adult Acute Lymphoblastic Leukemia (ALL)

Minimal residual disease (MRD) is the amount of disease detected by molecular or cellular means when the patient is in a clinical and pathological state of remission after treatment of leukemia. The goals of this project are to assess whether MRD may be an endpoint for use as a DDT and to standardize MRD measurement in adult precursor B-lineage ALL.

Biomarkers Consortium - High Definition Single Cell Analysis of Blood and Tissue Biopsies in Patients with Colorectal Cancer Undergoing Hepatic Metastasectomy

The project seeks to show that a liquid biopsy can serve as a source of rare circulating cells (CTCs) to comprehensively represent the traditional solid biopsy. The project is designed in two stages to demonstrate the correlation between liquid and solid biopsies in an observational clinical study with metastatic colorectal cancer (mCRC) patients undergoing resection of liver metastases.

Biomarkers Consortium - Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma

Build the case for FDA incorporation of FDG-PET into outcome measures for lung cancer and lymphoma.

Biomarkers Consortium - Carotid MRI Development and Validation via an AIMHIGH Sub-Study

The goal of this project was to conduct a 75-patient study at a total of 15 centers to determine the reproducibility of the non-invasive technique of carotid magnetic resonance imaging (CMRI). Results established a standardized carotid MRI protocol and determined, for the first time, that kinetic parameters of carotid atherosclerotic plaque are reproducible and can be used for multi-center studies.