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hello i am kushthari and i will be presenting the topic an emerging paradigm shift in trial design in oncology clinical trials advances in cancer research have led to an improved understanding of the molecular mechanisms of cancer and how the immune system responds to cancer as the science behind the therapeutic interventions has grown the clinical trial designs of phase 1 2 and 3 have evolved as well as you know the primary objective of a phase one study is to assess safety profile of a drug this is typically done via assessment of those limiting toxicities the commonly used phase one design in oncology can be categorized in three groups rule-based designs such as standard three-plus 3 design or accelerated titration design pk guided dose escalation design and model based designs the traditional rule-based designs are simple and easy to implement these are relatively safe and clinical friendly however there are many drawbacks first there is a general lack of any statistical foundation
