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Scholar Results 1 - 10 of about 95 citing Kaul: Good enough: a primer on the analysis and interpretation of noninferiority trials. (0.12 sec) 

ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST- …

- onlinejacc.org
JL Anderson, CD Adams, EM Antman, CR … - Journal of the American College of Cardiology, 2007 - Elsevier
Cited by 714 - Related articles - All 7 versions

Antithrombotic therapy in atrial fibrillation

- chestpubs.org
DE Singer, AS Go - Clinics in geriatric medicine, 2001 - Elsevier
Based solely on observational data, long-term anticoagulation has been a favored
therapy to prevent stroke in rheumatic AF. 47 It was unclear whether
anticoagulants would work in nonrheumatic AF or whether they would be ...
Cited by 554 - Related articles - BL Direct - All 17 versions

Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis

- hopkinsmedicine.org [PDF] 
JL Mas, G Chatellier, B Beyssen, A Branchereau … - New England Journal of Medicine, 2006 - content.nejm.org
Jean-Louis Mas, MD, Gilles Chatellier, MD, Bernard Beyssen, MD, Alain
Branchereau, MD, Thierry Moulin, MD, Jean-Pierre Becquemin, MD, Vincent Larrue,
MD, Michel Lièvre, MD, Didier Leys, MD, Ph.D., Jean-François Bonneville, ...
Cited by 493 - Related articles - BL Direct - All 27 versions

A review of activity indices and efficacy end points for clinical trials of medical therapy in …


GD'Haens, WJ Sandborn, BG Feagan, K Geboes, … - Gastroenterology, 2007 - Elsevier
Ulcerative colitis (UC) is a common gastrointestinal disorder in adults. Recent
advances in pathophysiology, immunology, and pharmaceutical science have
resulted in a large number of medications including biologic agents with ...
Cited by 81 - Related articles - All 22 versions

Hepatitis A vaccine versus immune globulin for postexposure prophylaxis

- colgahnp.com [PDF] 
JC Victor, AS Monto, TY Surdina, SZ … - New England Journal of Medicine, 2007 - content.nejm.org
Results Of 4524 contacts who underwent randomization, 1414 (31%) were
susceptible to hepatitis A virus and 1090 were eligible for the per-protocol
analysis. Among these contacts, 568 received hepatitis A vaccine and 522 ...
Cited by 37 - Related articles - BL Direct - All 11 versions

The FDA and the case of Ketek

- livertransplantattorney.com [PDF] 
DB Ross - New England Journal of Medicine, 2007 - content.nejm.org
Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek
(telithromycin), lauding it as the first of a new class of antimicrobial agents
that circumvent antibiotic resistance. Since then, Ketek has been linked to ...
Cited by 37 - Related articles - BL Direct - All 7 versions

ACE inhibitors in cardiovascular disease--unbeatable?

- sld.cu [PDF] 
JJV McMurray - The New England journal of medicine, 2008 - nejm.highwire.org
The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint
Trial (ONTARGET, NCT00153101 [ClinicalTrials.gov] ), reported by Yusuf et al. 1
in this issue of the Journal, has important lessons for clinical practice ...
Cited by 31 - Related articles - BL Direct - All 7 versions

Oral drug therapy for multiple neglected tropical diseases: a systematic review

- globalnetwork.org [PDF] 
M Reddy, SS Gill, SR Kalkar, W Wu, PJ … - JAMA, 2007 - Am Med Assoc
Context The neglected tropical diseases include 13 conditions that occur in
areas of extreme poverty and are poverty promoting. The neglected tropical
diseases produce a disease burden almost as great as that associated with ...
Cited by 36 - Related articles - BL Direct - All 23 versions

Non-inferiority trials are unethical because they disregard patients' interests


S Garattini, V Bertele' - The Lancet, 2007 - Elsevier
Equivalence trials 1 have been widely used to assess new drugs, but have
recently lost ground to a non-inferiority design. This type of trial is usually
accepted by regulatory authorities for approval of new drugs or new ...
Cited by 31 - Related articles - All 7 versions

Current issues in non-inferiority trials


TR Fleming - Statistics in Medicine, 2008 - interscience.wiley.com
Non-inferiority (NI) trials enable a direct comparison of the relative
benefit-to-risk profiles of an experimental intervention and a standard-of-care
regimen. When the standard has clinical efficacy of substantial magnitude ...
Cited by 18 - Related articles - BL Direct - All 2 versions


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