Friday, January 10, 2014 9:43:53 PM
If a patient in a phase 1 clinical trial sees efficacy with a life-saving drug on an "incurable" disease and their cohort has come to an end, are they able to start treatment doses with that drug? If so, would that open up immediate phase 2 trials for that particular strain of disease? What I worry about is someone seeing tumor shrinkage this late in the trials, and then they have to stop taking K because there isn't a planned phase 2 trial for their particular type of cancer. How horrible would it be to expect death, be given hope through a new treatment, and then have it all taken away from you because of government regulations?!
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