Aetion partnership to replicate clinical trials with real-world evidence

Analytics software company Aetion Inc. (New York, N.Y.) partnered with FDA and Brigham and Women’s Hospital to recreate 30 published clinical trials using real-world evidence (RWE) in order to determine if the data can be used to supplement or replace clinical trials.

Aetion is using its Aetion Evidence Platform to attempt to replicate the results of the clinical trials -- 23 that led to approval and seven which led to rejections -- in cardiovascular, endocrinological, musculoskeletal and pulmonary disease indications. The company is aiming to show RWE could be used to speed drug approval, especially for follow-on indications. The three-year project, which is being funded by FDA's CDER and led by the Office of Medical Policy, began last fall...