Drug Safety

Drug Safety

Ongoing efforts are underway to improve the safety of therapeutic drugs and medical devices, both through rigorous testing before their approval by the FDA and monitoring throughout the duration of their use.

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. 

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, Research Partners

Drug-Induced Liver Injury Network (DILIN)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) created the Drug-Induced Liver Injury Network to collect and carefully analyze cases of liver injury caused by prescription and non-prescription drugs, nutritional supplements and herbal remedies. 

Completed Programs, Past Programs

Best Pharmaceuticals for Children

The Best Pharmaceuticals for Children Act of 2002 provided for the testing of drugs that had been approved for adult use and that are used to treat children, but had not been tested for children.