The ethics of non-inferiority trials/Authors' reply

Improving on such high cure rates is almost impossible, but shortening treatment duration would improve completion rates and reduce both the time that patients are exposed to potentially toxic drugs and the cost of delivering tuberculosis chemotherapy in the developing world where resources are seve...

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Bibliographic Details
Published inThe Lancet (British edition) Vol. 371; no. 9616; p. 895
Main Authors Nunn, Andrew J, Meredith, Sarah K, Spigelman, Melvin K, Ginsberg, Ann M, Gillespie, Stephen H, Gandjour, Afschin, Soliman, Elsayed Z, Chuang-Stein, Christy, Beltangady, Mohan, Dunne, Michael, Morrison, Briggs, Menten, Joris, Boelaert, Marleen, Garattini, Silvio, Bertele, Vittorio
Format Journal Article
LanguageEnglish
Published London Elsevier Limited 15.03.2008
Subjects
Advantages
Antibiotics
Chemotherapy
Clinical outcomes
Clinical trials
Cost control
Design
Drug resistance
Health economics
Medical ethics
Medical research
Mortality
Patients
Public health
Sample size
Toxicity
Tuberculosis
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Summary:Improving on such high cure rates is almost impossible, but shortening treatment duration would improve completion rates and reduce both the time that patients are exposed to potentially toxic drugs and the cost of delivering tuberculosis chemotherapy in the developing world where resources are severely stretched-important medical and public-health goals. With protective therapies (eg, rotavirus vaccine), trialists stipulate that the relative risk of undesirable outcome (eg, intestinal intussusception) should be within acceptable bounds.3 Because efficacy and safety assessments remain separate, and only considered together when making the final decision, testing for comparability or non-inferiority in one of these dimensions is often inevitable.\n Lancet 2007; 370:1875-77.
ISSN:0140-6736
1474-547X