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.

Sports and Health Research Program

The Sports and Health Research Program (SHRP) sought to help accelerate research that enhances the health of athletes at all ages and levels, and to extend the research’s impact beyond the playing field to benefit others in the general population, including members of the military.

Sports and Health Research Program: Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research

Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research was a component of the Sports and Health Research Program (SHRP) that funds pilot projects for research on sports-related traumatic brain injury and spinal cord injury research.

Sports and Health Research Program: Chronic Traumatic Encephalopathy and Delayed Effects of Traumatic Brain Injury

Chronic Traumatic Encephalopathy and Delayed Effects of Traumatic Brain Injury was a component of the Sports and Health Research Program. It sought to more fully characterize the neuropathology associated with chronic traumatic encephalopathy (CTE) and delayed effects of traumatic brain injury through systematic, rigorous and collaborative studies of post-mortem biospecimens.

Biomarkers Consortium - Workshop: Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification

This workshop aimed at creating alignment among scientific stakeholders including the FDA, the NIH, the biopharmaceutical industry, academic researchers and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development.

Biomarkers Consortium - Use of Targeted Multiplex Proteomic Strategies to Identify CSF-Based Biomarkers in Alzheimer’s Disease

The AD Targeted Cerebrospinal Fluid (CSF) Proteomics Project, completed in Q2Y15, completed an initial validation of a multiplexed panel of known biomarkers, examined BACE levels and enzymatic activity, and set up the initial validation of a mass spectroscopy panel using AD cerebrospinal fluid samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

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 - 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 - 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.