Transcription of Efficacy endpoints in Oncology - Lex Jansen
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Efficacy endpoints in Oncology - Lex Jansen
PhUSE 2013 1 Paper IS01 Efficacy endpoints in Oncology Angelo Tinazzi, cytel Inc., Geneva, Switzerland ABSTRACT The evaluation of Efficacy in Oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance ( EMA and FDA), including some specific cancer type guidance ( NSCLC from FDA). Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors Efficacy endpoints . Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key Efficacy indicators that will be discussed.
PhUSE 2013 1 Paper IS01 Efficacy endpoints in Oncology Angelo Tinazzi, Cytel Inc., Geneva, Switzerland ABSTRACT The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several
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