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Abstract:
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Clinical trials are typically designed to ensure one primary objective is attained. In cancer clinical trials this may involve tumor response rates, progression free survival or overall survival. However, the ultimate use and effectiveness of a treatment is influenced by other risk factors that include the safety and tolerability of the treatment. Depending on the magnitude of the benefit, more or less risk may acceptable, but no clear quantification of the risk to benefit relation is available. I will present some examples from recent clinical trials along with potential risk benefit measures to compare approaches and discuss pros and cons of each.
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