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VaxGen, Inc. (VXGN) Message Board

  • markity markity Sep 10, 2003 6:41 PM Flag

    clinical trial phases

    Just to clear up any confusion regarding phases of clinical trials:
    What are the clinical trial phases?

    Phase 1: These studies involve a small group of people who all take the same drug but have different methods of delivery and/or different dosages. This phase tests the safety and dosage of the drug.
    Phase 2: These studies focus on comparing the new treatment with the current standard treatment or placebo. Larger than phase 1 studies, phase 2 studies continue to test the drug safety and efficacy.

    Phase 3: These are large trials that randomize patients to test the effects of the new treatment without bias from researchers. Phase 3 studies test the effectiveness of the drug as well as potential side effects. Safety of the drug also is monitored.

    Phase 4: These studies occur after the FDA has approved the drug for use in the United States. Phase 4 studies usually concentrate on possible new indications or long-term effects of the drug.These studies may include testing use in specific groups such as children or the elderly.

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    • For this kind of products like Anthrax do NOT need a Phase I, Phase II etc....the governement is above the FDA and can decide (if it finds data compelling) and for security reasons to approve the product and give it to the people. DO NOT CONFUSE WITH A NORMAL Phase I etc.....That's why the stock will be a shock on the upside if the government will give tham the ok because nobody understands this....better for us longs...

    • Markity .. We obviously Cant do a Phase 3 or any other Effaxcy study on humans .. Not even prisoners would allow themselves to be exposed to smallpox or anthrax and given a placebo or for that matter a guaranteed effective sized dose of the real drug .. There is no confusion here about the common phases of clinical trials but some people fail to realise that this BioTerrorism and GermWarfare Buisness is a Different Kettle of Fish all togeather .. See What I Mean ?? If it works on animals (It Does) and it is safe for humans (This class of Vaccines have a Wonderful safety profile whitch is why the DOD demands that this be the only type used)We Are In ..