CLINICAL TRIALS

Before a drug can be offered to the public it must go through several phases of rigorous testing to make sure it is safe, efficient and does what it says it can do. The testing is mandated and overseen by the U.S. Food and Drug Administration (FDA) which is part of the U.S. Department of Health and Human Services.

Under the “Useful Resources” link on the Samaritan Web site there are detailed descriptions of the drug testing process set up by the FDA.

Briefly, however, each drug starts out as an idea which grows into a laboratory test. If successful, the laboratory test becomes a series of preclinical tests, and could eventually involve testing with animals. If the drug continues to show promise, an investigational new drug (IND) application is sought from the FDA. With approval of the IND, the first of three phases of clinical trials may begin, this time using real people. Assuming all the clinical trials are successful, a new drug application (NDA) is applied for from the FDA and a new drug is on the market.

All of the above may sound simple, but it isn’t. The approval of a drug may take more than 15 years and cost over $1 billion. And, according to the FDA, of every 5,000 drugs submitted for initial approval, only five are selected to proceed to clinical trials, and only one of the five can expect to be granted an NDA status.

To see the testing results of Samaritan’s HIV drug SP-01A, click on the
links located on the right-side of the page.