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.

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. 

Buprenorphine/naloxone was a treatment system for opiate addiction. This study, overseen by the National Institute on Drug Abuse (NIDA), compared buprenorphone/naloxone and methadone, an opiate used in the treatment of opiate addicts. It was 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.

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.