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brainy, thank you for your spiel on cancer cures. I know, and...

  1. 244 Posts.
    brainy, thank you for your spiel on cancer cures. I know, and most people should know that this is not a cure. You are going on about a point that was not the issue.

    i was replying to this post of yours

    "If Phase2b results show that it saves lives of the terminally ill, I know what the SP will do."

    This quote was the basis of your original post, and there is not a word of truth in it. Like i said, the Phase 2b trial is not in terminally ill patients. You seemed to have corrected yourself slightly in your most recent post, but i think you need to understand how drug trials work

    The reason Phase 2a is performed in terminally ill patients is to test the safety of the drug. Ethics approval is only allowed to test for the safety of a drug in terminally ill patients. They do not want to give the drug to someone who is not terminally ill, in remission, in case it is dangerous.

    Now, Phase 2a has shown it to be safe. Interestingly, it has shown it to slow progression down in 4/21 participants enrolled in the trial. This was not the main outcome of the study, but obviously an interesting result.

    Phase 2b isn't recruiting healthier patients for better remission results...Phase2b is the first trial recruiting patients who are actually in remission, to test the efficacy of CVAC on PFS. People are in first line or second line of treatment. It is NOT a double-blind placebo controlled trial, and only has 63 people. Those randomized to the control group receive standard care. You will be lucky to find any sort of meaningful statistical significance from this trial. What they will hopefully get is enough data to appropriately estimate how many participants they will need for CANVAS. I know they are already aiming to recruit around 800...but this number will probably change once they have completed the phase2b trial, and can perform power calculations on the data they have collected

    CANVAS is a double-blind placebo controlled study. This is the best way to test a drug properly, and only in this trial will they be able to prove anything. The results from the 2a and 2b trial will be of interest, but don't hold your breath too much.....

 
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