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
- electronic health record
- case report
- transcription factor
- current status
- left ventricular
- big data
- randomized controlled trial
- atrial fibrillation
- acute heart failure
- human health
- machine learning
- cardiac resynchronization therapy
- phase ii
- risk assessment
- open label
- phase iii
- data analysis