Streamlining Randomized Clinical Trials for Device Therapies in Heart Failure: Bayesian Borrowing of External Data.
Benjamin R SavilleDaniel BurkhoffWilliam T AbrahamPublished in: Journal of the American Heart Association (2024)
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.
Keyphrases
- drug administration
- heart failure
- clinical trial
- case report
- electronic health record
- quality improvement
- transcription factor
- current status
- big data
- left ventricular
- randomized controlled trial
- atrial fibrillation
- machine learning
- study protocol
- data analysis
- double blind
- acute heart failure
- artificial intelligence