PCL102H1 Lecture Notes - Lecture 15: Adaptive Clinical Trial, Mammaprint, Neoadjuvant Therapy
16 Mar 2019
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Lecture 15: clinical trial designs with a personalized medicine approach. The "ispy-2 trial" or investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2 is an adaptive phase 2 clinical trial. In these trials biomarkers in key for both deciding which therapy is given to which patient, and for deciding whether or not the therapy is working. In traditional clinical trials there is one agent and one primary endpoint, the aim is to benefit the average patient - by defn. Have of the patients have below-average success in these trials. In contrast, adaptive clinical trial platforms are patient-centered and aims to cure disease for each and every patient, therefore, there is the use of multiple different drugs available but still one primary endpoint. For changing clinical trial designs, we need to be able to: Introduce and rapidly evaluate new drugs: target women at high risk for recurrence.
