Before a drug is approved by the Food and Drug Administration and brought to market, it must be tested via clinical trials. Trials go through a number of steps, or phases, labeled I, II, III and IV, says the National Institutes of Health, and each is done to address various issues such as safety and efficacy. Phase I typically involves a small number of people, with researchers examining safety and side effects and determining appropriate doses. In Phase II more people are involved, and safety and effectiveness are again studied. Phase III involves even larger groups, and in addition to looking at safety and side effects, the drug is compared to other existing treatments. Phase IV trials are done following a drug’s approval to make sure of its effectiveness and to monitor any long-term side effects.
Drugs that have already been approved for one purpose but want to win approval for another still must go through the trial process.
A drug called Abraxane showed promise for extending the life of people with metastatic melanoma in a late-stage clinical trial, Reuters reports. The medication, made by Celgene Corp., is currently approved for breast cancer patients who have shown no response to other treatments. The company is seeking approval for it to be marketed to treat other forms of cancer, specifically pancreatic cancers and melanoma.
Click through the gallery to see what other medications are showing promise in trials.
Photo: Celgene Corp
Andrew Freeman is a California native with a degree in history from UCLA. He’s covered a wide range of topics for TakePart, but is particularly interested in politics and policy. Email Andrew |@natureofdabeast | TakePart.com
