The objective of a pivotal clinical trial is to evaluate a new drug, given in a defined manner, has a medical utility for a defined hypothesis about treatment effectiveness in specified patient population groups. It is not a exploratory study with defined outcome variables, is randomized, well controlled and a hypothesis to be validated in a given patient population. The term "pivotal" refers to the key decision making point.
From a sponsor point of view the results are presented in major congresses or confernces and usually receive most media attention. From a data manager or research co-ordinator perspective pivotal trials are multinational and complex. This will be the first exposure of the data and results to key regulatory input so it will mean great visibility to your good work !!!
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