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.

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 - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.

Biomarkers Consortium - Sarcopenia as a Valid Biomarker for Identifying Individuals at Risk of Disability

Sarcopenia 2 seeks to establish evidence-based cut-points for muscle mass and strength and determine their predictive validity for clinically meaningful outcomes (such as mobility, fractures, hospitalization and death); evaluate relative strength as a discriminator for mobility limitation and incident disability; and explore the potential usefulness of sarcopenia as a clinical endpoint in randomized clinical trials.

Biomarkers Consortium - Establish Guidelines for Initial Diagnostic Criteria for “Sarcopenia with Clinically Important Weakness” and Associated Evidence for Treatment Benefit

The Sarcopenia 1 project launched in 2010 and aimed to establish the first evidence-based definition of sarcopenia (muscle weakness), which is still not recognized as a medical condition.

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 - I-SPY TRIAL-2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and MoLecular Analysis): An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

Phase II trial of novel investigative breast cancer agents in the neoadjuvant setting that uses biomarkers and adaptive design to accelerate the clinical trial process.

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.