Streamlining Randomized Clinical Trials for Device Therapies in Heart Failure: Bayesian Borrowing of External Data
BR Saville, D Burkhoff, WT Abraham - Journal of the American …, 2024 - Am Heart Assoc
BR Saville, D Burkhoff, WT Abraham
Journal of the American Heart Association, 2024•Am Heart AssocBackground The Breakthrough Devices Program of the US Food and Drug Administration
has accelerated the development and evaluation of medical devices for patients with heart
failure. One such device is the Optimizer Smart System, which the US Food and Drug
Administration approved in 2019. Methods and Results The Optimizer device was evaluated
in a pivotal randomized clinical trial (FIX‐HF‐5C [Confirmatory Randomized Trial Evaluating
the Optimizer System]) that leveraged Bayesian borrowing of external data to reduce the …
has accelerated the development and evaluation of medical devices for patients with heart
failure. One such device is the Optimizer Smart System, which the US Food and Drug
Administration approved in 2019. Methods and Results The Optimizer device was evaluated
in a pivotal randomized clinical trial (FIX‐HF‐5C [Confirmatory Randomized Trial Evaluating
the Optimizer System]) that leveraged Bayesian borrowing of external data to reduce the …
Background
The Breakthrough Devices Program of the US Food and Drug Administration has accelerated the development and evaluation of medical devices for patients with heart failure. One such device is the Optimizer Smart System, which the US Food and Drug Administration approved in 2019.
Methods and Results
The Optimizer device was evaluated in a pivotal randomized clinical trial (FIX‐HF‐5C [Confirmatory Randomized Trial Evaluating the Optimizer System]) that leveraged Bayesian borrowing of external data to reduce the sample size and determine therapeutic device benefit versus continued medical therapy. Bayesian borrowing is explained in the context of the FIX‐HF‐5C trial, including an overview of the statistical methodologies, regulatory considerations, and interpretations of trial results.
Conclusions
The US Food and Drug Administration Breakthrough Devices Program and novel Bayesian statistical methodology accelerated the path to regulatory approval and patient access to a potentially lifesaving device and may serve as a model for future clinical trials.
Am Heart Assoc
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