Clinical & Patient Support | Foundation for the National Institutes of Health

Clinical trials are a crucial step in the development of new patient therapies and interventions. Foundation programs work at supporting safe and effective trials and improving the diagnosis and treatment of patients.

Key Initiatives, Research Partners

Observational Medical Outcomes Partnership (OMOP)

A scientific research initiative designed to improve the safety of drugs on the market, OMOP utilizes information drawn from patient medical record databases and health insurance claims to develop and test methods to detect and evaluate drug safety issues over time.

Key Initiatives, Research Partners

I-SPY 2: Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis

The I-SPY 2 trial employs a groundbreaking clinical trial model that uses genetic or biological markers (“biomarkers”) from individual patients’ tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients. In addition, an innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly. The large-scale trial involves a unique collaboration by scientists from the National Cancer Institute (NCI), FDA, and nearly 20 major cancer research centers across the country. Study results will be made broadly available to the entire cancer research and development community.

Program, Research Partners

Clinical Center Drug Donation Program

This program seeks in-kind drug donations from pharmaceutical companies that supply the pharmacy at the National Institutes of Health Clinical Center with pharmaceuticals and products for patient care. Donations alleviate the financial burden on the Clinical Center and free up financial resources to support medical research.

Completed Programs, Program

Psychiatric GWAS Consortium

The overarching goal of the consortium is to conduct a rigorous set of analyses of GWAS data for Attention Deficit Hyperactivity Disorder, autism, bipolar disorder, major depression disorder, and schizophrenia, utilizing the knowledge and capabilities of the contributing groups to accomplish analyses that can help move the entire field of mental health genetic research forward.

Program, Research Partners

Neurotopin Research Project

The National Institute of Nursing Research, with private-sector support from Nippon Zoki Pharmaceuticals Co., Ltd., is conducting two clinical trials on the investigational drug, Neurotropin, for the treatment of complex regional pain syndrome and fibromyalgia. Currently, no effective drug treatments exist for these chronic pain disorders. The Foundation for NIH raised $300,000 from the private sector to support this project.

Program, Research Partners

Endotoxin Research Project

The use of bacterial endotoxin in clinical research is essential to the study of the effects of inflammation on the body and as a potent stimulus to enhance immune responses in clinical trials of anti-cancer immunotherapy.

Completed Programs, Program

Buprenrorphine/Naloxone

Buprenorphine/naloxone is a treatment system for opiate addiction. This study, overseen by the National Institute on Drug Abuse (NIDA), compares buprenorphone/naloxone and methadone, a synethetic opiate that is also used in the treatment of opiate addicts. It is expected to determine the effect of both treatment systems on liver enzymes and identify risk factors that contribute to liver injury or dysfunction. The Foundation for NIH raised $1.9 million from the private sector for this project.

Completed Programs, Program

Equivalence Among Antiepileptic Drug Generic and Brand Formulations

Phase I of this project, initiated by the American Epilepsy Society supports protocol development for clinical trials needed to address the safety of widespread use of generic antiepileptic drug formulations.

Program

The Edmond J. Safra Family Lodge

Since its opening in 2005, the Edmond J. Safra Family Lodge has welcomed more than 74,000 family caregivers from around the world, providing a rejuvenating haven from the stresses that serious illness of a loved one can impose.

Completed Programs, Program

Overcoming Barriers to Early Phase Clinical Trials

This program, through the National Cancer Institute (NCI), provided approximately $6 million to cancer centers to design and implement new approaches to increase patient participation in early-stage clinical trials—particularly in minority and underserved populations.