Therapy Areas: Cardiovascular
The US FDA & Brigham and Women's Hospital/Harvard Medical School to use Aetion's software platform to re-create RCTs through RWE
9 May 2018 -

Health care technology company Aetion reported on Tuesday that it has entered into a partnership with the US Food & Drug Administration (FDA) and Brigham and Women's Hospital/Harvard Medical School to apply the Aetion Evidence Platform in exploring the potential of real-world analyses in advancing regulatory process for critical treatments.

This landmark study aims to demonstrate the value of RWE (real-world evidence) as an accelerant to drug approval, particularly for supplemental indications. Aetion's software platform will re-create randomized clinical trials (RCTs) through real-world evidence (RWE).

Under the 21st Century Cures Act and Prescription Drug User Fee Act VI, the US FDA-sponsored research study employs the Aetion Evidence Platform at replicating the results of 30 published RCTs, to see whether the use of RWE would have led to the same regulatory decisions. The results will demonstrate whether RWE could be used to supplement or, in certain circumstances, even replace clinical trials for drug development and regulatory approval.

Of the 30 trials to be replicated (cardiovascular, endocrinology, musculoskeletal and pulmonary), 23 involved positive decisions, added the partnership.

The three-year study began in fall 2017 and is funded by the US FDA's Center for Drug Evaluation and Research and is led by the Office of Medical Policy.

Additionally, the Aetion Evidence Platform uses the everyday clinical and financial interactions of the health care system to unlock essential evidence about the effectiveness and value of treatments. Its validated, rapid-cycle analytics allows users to significantly reduce "time to evidence" and improve patient outcomes.



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