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clinical trials - the different phases

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    Its a quiet day at the office today so I thought I would do a bit of research on the Clinical Trials process.

    Most of you probably already know this but I was interested to find out that the trials(Phase I,II,II & IV) themselves are the same, what changes in each trial is simply the number of people involved in each trial.

    See below copy and paste from the following website:

    http://clinicaltrials.gov/ct2/info/understand#Q19

    +++++++++++++++++++++++++++++++++++++++++++++++++++++++
    What are the phases of clinical trials?

    Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

    In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

    In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

    In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

    In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
    +++++++++++++++++++++++++++++++++++++++++++++++++++++++++


    So I would assume that the product remains the same from Phase I through to Phase IV.

    CVac is CVac for the whole journey and if it has been successful through Phase I & II (100-300 people) you would think that it stands an excellent chance of being successful with Phase III (1000-3000 people.)

    Just food for thought and apologies to all who already know this.

    Dakook



 
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