Advancing Real World Evidence Under FDA Commissioner Califf

As part of his new role as FDA Commissioner, Robert Califf has pledged to promote the use of real-world evidence (RWE) in FDA decision-making. Expanding RWE data infrastructure can allow for new clinical endpoints that were previously inaccessible, helping refine clinical trials to grow understanding of disease mechanisms and develop new treatments.

According to Gail Dutton of Biospace, “Additional goals include using RWE to shorten the drug development process and to also change physicians’ practice behaviors. Incorporating RWE into real-time predictive models using data from multiple sources enables drug developers and physicians get a better notion of whether a particular treatment makes sense for an individual patient.”

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(Source: Biospace, March 7^th, 2022)