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Phase I Clinical Trials

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Please explain Phase I Clinical Trials (in layman's terms) and explain the randomization and/or estimation implications for the phase. Please provide a specific example of this from the following journal article. Thank you.

Reference:
Harper, F. W., Heath, E. I., Gleason, M. E., Penner, L., LoRusso, P., Wang, D., & Albrecht, T. L. (2012). Physicians' Use of Patients' Daily Reports of Quality of Life to Evaluate Treatment Response in Phase I Cancer Trials. Journal of Cancer Therapy, 3, 582-588.

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This solution is comprised of a detailed explanation of Phase I clinical trials. In this solution, a description of result and information is provided based on the reference paper mentioned in the question. Also the randomization and other important aspects are discussed in the solution.

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After the successful investigation of pre-clinical of the drug on animals, the treatment of interest applied first time on the human beings to decide the maximum tolerated drug. This process is known as Phase I Clinical Trials. The phase I studies are carried out in healthy ...

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