What is a Seamless Trial? Also called a combined-phase study, the idea behind a seamless trial is simple: Instead of conducting several phases of a study, plan one adaptive trial where the phases are separated by interim looks. This tends to save time and reduce the number of patients.

В отличие от традиционных клинических испытаний, клинические испытания объединяют две или более фазы в одно исследование с адаптивным дизайном.


Seamless Clinical Trials: Why Didn’t We Think of That?

Traditional Clinical Trials
We are all familiar with the traditional phases of full clinical development programs, in which each phase is designed to establish separate goals.

The traditional paradigm is modified slightly in oncology trials in which Phase 1 goals typically include safety/tolerability, and dose; Phase 2 explores drug activity in a variety of cancers; and Phase 3 studies compare the efficacy of drug with existing treatments1.

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