Evidence strength in FDA premarket approval of cardiovascular devices

JAMA

Volumn 303, Issue 16, 2010, Pages 1599-1600

  Kong, David F ^a   Hasselblad, Vic ^a   Krucoff, Mitchell W ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BAYES THEOREM; CARDIOVASCULAR EQUIPMENT; CLINICAL EFFECTIVENESS; DECISION MAKING; DRUG ELUTING STENT; EXPOSURE; FOOD AND DRUG ADMINISTRATION; LETTER; PRIORITY JOURNAL; SAFETY; STENT THROMBOSIS; UNITED STATES; APPARATUS, EQUIPMENT AND SUPPLIES; CARDIOVASCULAR DISEASE; CLASSIFICATION; NOTE; RANDOMIZED CONTROLLED TRIAL; RISK; STANDARD; UNCERTAINTY;

CARDIOVASCULAR DISEASES; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK; UNCERTAINTY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77951650222     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2010.511     Document Type: Letter

References (5)

1. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302(24):2679-2685.
2. Temple R. How FDA currently makes decisions on clinical studies. Clin Trials. 2005;2(4):276-281. (Pubitemid 41306267)
3. Chen E, Sapirstein W, Ahn C, Swain J, Zuckerman B. FDA perspective on clinical trial design for cardiovascular devices. Ann Thorac Surg. 2006;82(3):773-775. (Pubitemid 44246744)
4. Guidance for the use of Bayesian statistics in medical device clinical trials. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm071072.htm. Accessed March 19, 2010.
5. Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: ameta-analysis of randomized clinical trials.AmJMed. 2006;119(12):1056-1061. (Pubitemid 44826931)