Lab+11_New+Cancer+Therapy - Graham Barnett Carly...

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Graham Barnett Carly Kruchten-Sharidan Poev Touch Nov. 30 2006 Lab 11 – New Strategies in Cancer Therapy 1) Describe the characteristics of each of the three phases of clinical trials. For the time the video covers, in which phase is Endostatin? There are 3 phases to a clinical trial, before a drug can be approved for marketing. There is technically a 4 th phase which is post marketing after the drug has been approved which is used to further determine how well the long-term safety and effectiveness of the drug is in clinical settings. With respects to Endostatin, it was in the Phase I clinical trial at the time of the video. Phase I deals primarily with the safety of the new drug. It involves anywhere between 15 to 30 people. This phase is mainly looking for the side effects of the treatment more than efficacy. This phase is also used to determine how the treatment should be given. Phase II primarily deals with the activity of a new drug. It involves anywhere between 30 to 70 people. This phase is mainly looking for the efficacy of the new treatment, to see how well it is actually working. This also includes analyzing the risk versus benefit of the treatment. Phase III focuses on a comparison of the new drug between different treatment options and between different people. It involves anywhere between 100 to several 1000 people. This phase compares the new treatment option with the current standard. It also looks for both efficacy and side effects on a larger scale with a larger
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This lab report was uploaded on 04/07/2008 for the course PHRM 223 taught by Professor Gerald during the Fall '05 term at UConn.

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Lab+11_New+Cancer+Therapy - Graham Barnett Carly...

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