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I've been asked about what the "phase" means in "Phase III Clinical Study", or which phase is the human trials? So I found this nifty little graph that illustrates what a "phase" is:
And MD Anderson Cancer Center does a good job of breaking it all down for you. I think in the past I thought Phase I was the lab testing, Phase II was animal testing, and Phase III was human testing, but that's apparently not the case.
Basically, Preclinical trials are to see if it produces an immune response at all. Phase I is to see if it's safe for human use and will it produce a human immune response. Phase II is to determine the best dose in addition to safety and how much of an immune response. Phase III is where we determine if it works, and if it works better than current or standard treatments. Phase IV is really about post-marketing data. Verifying efficacy and side-effects among the general population occurs during this phase, mostly to see how effective it works over time. Phase IV is done on treatments that have already received FDA approval and is in use in the general population.
There are about 10 years or more between studying something in the lab and getting it to market. So a lot of the nifty new research I talk about here is almost a decade away from ever being found on the store shelves or prescribed by your doctor.
But if you see something labeled "Phase III Clinical Trial", you can start getting excited!
And MD Anderson Cancer Center does a good job of breaking it all down for you. I think in the past I thought Phase I was the lab testing, Phase II was animal testing, and Phase III was human testing, but that's apparently not the case.
Basically, Preclinical trials are to see if it produces an immune response at all. Phase I is to see if it's safe for human use and will it produce a human immune response. Phase II is to determine the best dose in addition to safety and how much of an immune response. Phase III is where we determine if it works, and if it works better than current or standard treatments. Phase IV is really about post-marketing data. Verifying efficacy and side-effects among the general population occurs during this phase, mostly to see how effective it works over time. Phase IV is done on treatments that have already received FDA approval and is in use in the general population.
There are about 10 years or more between studying something in the lab and getting it to market. So a lot of the nifty new research I talk about here is almost a decade away from ever being found on the store shelves or prescribed by your doctor.
But if you see something labeled "Phase III Clinical Trial", you can start getting excited!
