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.

Accelerating Medicines Partnership – Schizophrenia

The Accelerating Medicines Partnership–Schizophrenia is the first neuropsychiatric project of the landmark Accelerating Medicines Partnership program managed by the Foundation for the National Institutes of Health.

NINDS Healthcare Disparities in Tribal Communities Summer Internship Program

The NINDS Healthcare Disparities in Tribal Communities (HDTC) Summer Internship Program (SIP) is a student research training program in brain and nervous system research. The program focuses on neurological disorders and healthcare disparities and seeks to provide research experiences and career development opportunities for Native American students, along with students from other underrepresented communities.

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: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.

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 - 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 - 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 - The Autism Biomarkers Consortium for Clinical Trials (ABC-CT)

The Consortium will establish a technical and data infrastructure for reliably measuring social function, allowing the collaborating sites to work together as a single unit. The goal is to create a set of measures that can be used in clinical trials to determine which treatments are best for which patients and who will benefit from a particular treatment. The ultimate goal is to further develop and validate a set of measures that can be used as stratification biomarkers and/or sensitive and reliable objective measures of social impairment in autism spectrum disorders that could serve as indicative markers of long term clinical outcome.