The value and purpose of a Phase IV clinical study is to increase the knowledge surrounding a new drug, the disease for which the drug treats, and to build awareness of the therapy as the drug rolls out into the market. These trials can be called post-marketing trials and are critical for tracking side effects, exploring new uses for the therapy, as well as garnering a full understanding of the capability and uses of the drug. These trials are very heavily scrutinized because many critics say that the primary reason many companies conduct trials is for promotional purposes. Therefore, assuring the trial has significant scientific value is of critical importance. There are a number of important considerations involved in the development, design and conduct of a large-scale phase IV or post-marketing trial. This conference will address the key challenges associated with conducting a phase IV trial and the various methods and opportunities available for addressing these obstacles.
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