Wednesday, June 25, 2008

The ExpIND and the phase 0 clinical trial

I have a deep interest in cancer pharmacology and drug development. My dissertation project involves studying the mechanism of action of a novel analog of the spice curcumin which may be a potential chemotherapeutic in the future. Excitingly, this compound is entering phase 0 clinical trials for head & neck cancer to be led by my PI and research physicians at the cancer institute. I had never heard of phase 0 clinical trials before this, and I was even asked about it at a recent oral presentation, proving that this is a new and little known development in clinical trial design and execution. In my first couple of years in graduate school, we learned about the traditional phase I-II clinical trials, even the post-marketing phase IV trial for safety surveillance. The basic clinical testing structure has changed very little over the past 30 years. So what is a phase 0 trial?...

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