What is a clinical trial?
By bitzi
3 times a charm
Doctor Wolchok from Memorial Sloan-Kettering hospital wrote this morning to say that Rusty has been accepted into its Phase 2 clinical trial for melanoma. This is a huge relief. After almost a month of waiting, we were beginning to worry we’d have to look for an alternative treatment. Rusty begins his first infusion tomorrow in New York.
Before a drug gets sold on the market in the US, it needs to be approved by the country’s Food and Drug Administration (FDA). To get FDA-approval, there are three phases of testing.
The first phase is to test the drug’s toxicity: What are the patients’ medical risks and side effects of taking it? Phase 2 tests the drug’s effectiveness by measuring its results against placebos: Does it really work?
In the last phase, the drug is tested again in different populations and protocols to determine its most ideal dosage. In phase 3, the patient size is also the largest, typically ranging from several hundred to about 3,000.
December 29th, 2006 at 2:35 am
[…] We are at Memorial Sloan Kettering on 53rd and Lexington Ave, and in a few minutes Jesse will receive another dose of the new drug, Medarex. This is the first time I am sitting with him through the treatment, even though it will already be his third infusion. There is one more infusion after this, and then we will take scans. Looking at the modest, palm-sized plastic bag of clear liquid, I wonder if this clinical trial is what will save our future. Instinctively, out of habit, I pray under my breath. […]