12:43 PM
Apr 10, 2019
 |  BC Extra  |  Clinical News

Aetion, Brigham and Women's partnerships will inform FDA RWE standards

Editor's Note: This article was updated on Apr 10, 2019 at 2:13 PM PDT

FDA is expanding its real-world evidence partnership with Brigham and Women's Hospital and Aetion to use real-world evidence to predict clinical outcomes from trials. The results from this expansion should help the agency identify when and how RWE could provide robust estimates of safety and efficacy to support sNDAs.

On Wednesday, the partners announced that they would use Aetion's platform and healthcare claims data to predict safety and efficacy outcomes of seven ongoing clinical trials.

The group has already completed a pilot study to predict the results of the CAROLINA cardiovascular outcomes trial. CAROLINA is a non-inferiority trial of Tradjenta linagliptin vs. glimepiride to assess cardiovascular events in patients with Type II diabetes.

Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) market Tradjenta. The companies reported in February that CAROLINA met its primary endpoint, but data were not disclosed. Full results will be reported in June.

Brigham and Women's said FDA is reviewing the results from the predictive RWE study for CAROLINA, which it submitted in January. "We hope it will be available online or at least accepted before June," the organization told BioCentury.

The group plans to start seven other prediction trials, which together with its earlier collaboration should help FDA establish standards to determine when and where RWE could replace the need for postmarketing studies or support supplemental drug applications.

Last May, Aetion Inc. (New York, N.Y.), FDA and Brigham and Women's partnered on a duplication project to recreate 30 published clinical trials using RWE (see "Aetion Partnership to Replicate Clinical Trials with Real-World Evidence").

Together, the program is known as RCT DUPLICATE, which is being managed by researchers within the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's. FDA collaborators include statisticians, epidemiologists and medical officers in various divisions.

Aetion is training FDA staff on its RWE platform to help them work with the technology to review a completed RWE study and test its robustness.

Full results from the duplication and prediction studies should be available by late 2020 but the group will release results from the projects on a rolling basis as they are completed.

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