The authors reply

New England Journal of Medicine

Volumn 365, Issue 24, 2011, Pages 2335-

  Patel, Manesh R ^a   Fox, Keith A A ^b   Califf, Robert M ^a  

^a DUKE UNIVERSITY   (United States)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; ANTIVITAMIN K; BLOOD CLOTTING FACTOR; RIVAROXABAN; VITAMIN K GROUP; WARFARIN;

BLEEDING; BRAIN HEMORRHAGE; CLINICAL PRACTICE; COMORBIDITY; DEMOGRAPHY; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HUMAN; INTENTION TO TREAT ANALYSIS; LETTER; NORTH AMERICA; PATIENT CARE; PHARMACOLOGICAL PARAMETERS; PHYSICIAN; PRIORITY JOURNAL; SKILL; SOCIAL ASPECT; TIME IN THE THERAPEUTIC RANGE;

EID: 84856169290     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: None     Document Type: Letter

References (4)

1. Matilde Sanchez M, Chen X. Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat. Stat Med 2006;25:1169-81.
2. Brittain E, Lin D. A comparison of intent-to-treat and perprotocol results in antibiotic non-inferiority trials. Stat Med 2005;24:1-10. (Pubitemid 40074060)
3. Guidance for industry: non-inferiority clinical trials (draft guidance) Silver Spring, MD: Food and Drug Administration, 2010 (http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf) .
4. Food and Drug Administration, Cardiovascular & Renal Drugs Advisory Committee. Meeting materials, September 8, 2011 (http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM277588.pdf).