Clinical trial designs incorporating predictive biomarkers.

摘要: Development of oncologic therapies has traditionally been performed in a sequence clinical trials intended to assess safety (phase I), preliminary efficacy II), and improvement over the standard care III) homogeneous (in terms tumor type disease stage) patient populations. As cancer become increasingly understood on molecular level, newer "targeted" drugs that inhibit specific cell growth survival mechanisms have increased need for new trial designs, wherein pertinent questions relationship between biomarkers response treatment can be answered. Herein, we review design literature from initial more recently proposed designs targeted agents or those treatments hypothesized enhanced effectiveness within subgroups (e.g., with certain biomarker value who harbor genetic mutation). We also describe number real where biomarker-based utilized, including discussion their respective advantages challenges. cancers further categorized and/or reclassified according individual features, anticipate continued novel keep pace changing frontier research.