Clinical & Patient Support

Clinical & Patient Support

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

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

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.

Program

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 resources to support medical research.
 

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

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

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.

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.

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 90,000 family caregivers from around the world, providing a rejuvenating haven from the stresses that serious illness of a loved one can impose.

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.

Education & Training

Clinical Research Training Program

Established in 1997, the Clinical Research Training Program (CRTP) is one of the Foundation for NIH’s premier public-private partnerships. With long-term support from Pfizer Inc, the program has enabled 280 of the country’s most promising medical and dental students to experience clinical research firsthand in an intensive, year-long, residential training program at the National Institutes of Health.

Programs in Development

The Heart Valve Exhibit: The Issue Was Patients: Developing Heart Valve Replacements

This planned exhibition and Web site will showcase the development of the heart valve, NIH’s role in its development, and the FDA’s role in regulation. The more personal side of research will be shared through the story of Dr. Nina Starr Braunwald, the first woman thoracic surgeon, as well as through the stories of some of the first heart-valve recipients.

Past Programs

The Edmond J. Safra Family Lodge (Construction)

One of the foundation’s earliest and largest capital programs, construction of the Edmond J. Safra Family Lodge was and is regarded as the anchor to our family-programs portfolio.

Past Programs

The Claudio and Evelyne Cohen Garden at the Safra Lodge

Families of patients with serious illness endure great stress in caring for and supporting their loved one undergoing care at the NIH Clinical Center.

Past Programs

Genetic Association Information Network (GAIN)

In 2007, the Genetic Association Information Network (GAIN) completed an ambitious program to genotype existing research studies in six major common diseases, and combine the results with clinical data to create a significant new resource for genetic researchers.

Past Programs

Minority Faculty & Student Partnership

The Minority Faculty-Student Partnership (MFSP) Traineeships in Biotechnology was a program of the National Institutes of Health and the Foundation for Advanced Education in the Sciences, Inc.